Recall from the FDA (Food and Drug Administration).
BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall
[Posted 09/15/2010]
ISSUE: Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation.
BACKGROUND: Westmed has become aware of a potential for disconnection at the patient port retention ring assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding units disconnecting during setup or use. The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities.
The good news is that this only seems to affect 3 facilities. The bad news is that is all that the FDA have been notified of, yet. Once people realize that there is a problem, they will probably realize that what they experienced and did not report was the same problem.
The description of the problem does not match the description of the product and the diagram on the manufacturer’s web site.
a potential for disconnection at the retention ring of the patient port manifold?
I am going to guess that they are referring to number 7. Exhalation port.
Between the PEEP valve and the patient.
With some BVMs (Bag Valve Masks, or resuscitators), this is relatively easy to work around, when dealing with a stable patient. Unfortunately, in EMS, the stable patients this is most likely to be used on is one who is too dead to be resuscitated. Also, from the diagram, there does not appear to be any easy way to make this work until another BVM is found. The wording of the recall suggests that this is the case – Disconnection causes the unit to be inoperable.
If you use these BVMs, consider using your pediatric BVM as a substitute. You really do not need all of that volume except on the largest patients. This is just one more reason not to separate your equipment into adult and pediatric bags. Consider placing 2 BVMs, rather than just 1, in your primary treatment bag. With the second one preferably from another manufacturer.
If the problem affects a batch of BVMs made at the same time, all of the supply you received may have the same problem. If it is a random problem, then carrying an extra BVM by Westmed should be adequate. The recall does not provide this information.
1. Lightly textured, highly pliant squeeze bag
2. Bias-closed fresh air inlet valve
3. Durable up-front oxygen reservoir
4. Flexible neck
5. Built-in adjustable PEEP valve
6. Two 360° swivels
7. Exhalation port
8. Oxygen reservoir bleed vent
9. Cushion facemask
10. Inflation/deflation valve (mask)
11. Integral pressure port (Child & Infant only)
12. Selectable high/low pressure pop-off valve (Child & Infant only)
Westmed BagEasy product information page with link to PDF
Westmed, Inc. Issues Nationwide Recall of BagEasy Manual Resuscitation Devices
Contact:
Customer Service, 1-800-975-7987
Representatives available M – F between 6 AM – 5 PM Arizona Standard Time
The above link includes all of the models and part numbers affected. It includes pediatric BVMs, too.
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hello
iam eager to know more about the use of the oxygen reservoir bleed vent, thank you