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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WESTMED LLC WESTMED; ADULT BAGEASY, RESUSCITATOR, W/PEEP AND MASK
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WESTMED LLC WESTMED; ADULT BAGEASY, RESUSCITATOR, W/PEEP AND MASK Back to Search Results
Model Number 562048
Device Problems Loose or Intermittent Connection (1371); Incomplete or Inadequate Connection (4037)
Patient Problem Decreased Respiratory Rate (2485)
Event Date 03/24/2023
Event Type  malfunction  
Event Description
Bags are leaking.  several incidents associated with same product which could of led to patient death.The bag is detached at the end of the bulb causing the leak in many of these ambu bags.Also, the valve tends to get stuck in one event.This is very serious and when emergencies occur and patients need to be resuscitated, there is no time to get another bag if defective products are further identified and patient may die.A facility reported there was a code in the er in which 4 ambu bags (also called bag valve mask) were used on one patient and all 4 were found to have a leak or fail to seal around the patient's mouth.Emergency tracheostomy had to be performed.A facility reported, a patient had a bronchospasm, and when the ambu bag was deployed, there were air leaks and unable to use.Another facility had patient crash and upon deploying ambubag, it had airleaks and the valve was stuck as well.
 
Manufacturer Narrative
The reservoir bag not staying attached and leaking would delay the ventilation of the patient.
 
Manufacturer Narrative
The reservoir bag not staying attached and leaking would delay the ventilation of the patient.Complaint was confirmed.Root cause could not be determined for if the complaint was due to assembly error or handling error when device was being prepped for use.Inventory could not repeat the reported defect; however, an additional inspection was created to ensure product maintains pull force consistency.
 
Event Description
Bags are leaking.  several incidents associated with same product which could of led to patient death.The bag is detached at the end of the bulb causing the leak in many of these ambu bags.Also, the valve tends to get stuck in one event.This is very serious and when emergencies occur and patients need to be resuscitated, there is no time to get another bag if defective products are further identified and patient may die.A facility reported there was a code in the er in which 4 ambu bags (also called bag valve mask) were used on one patient and all 4 were found to have a leak or fail to seal around the patient's mouth.Emergency tracheostomy had to be performed.A facility reported, a patient had a bronchospasm, and when the ambu bag was deployed, there were air leaks and unable to use.Another facility had patient crash and upon deploying ambubag, it had airleaks and the valve was stuck as well.
 
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Brand Name
WESTMED
Type of Device
ADULT BAGEASY, RESUSCITATOR, W/PEEP AND MASK
Manufacturer (Section D)
WESTMED LLC
5580 s nogales highway
tuscon AZ 85706
Manufacturer (Section G)
WESTMED LLC
5580 s nogales highway
tuscon AZ 85706
Manufacturer Contact
melissa brickley
2710 northridge dr nw suite a
grand rapids, MI 49544
6162598415
MDR Report Key16907472
MDR Text Key315105607
Report Number2028807-2023-00014
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number562048
Device Catalogue Number562048
Device Lot Number071122U10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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