MAUDE Adverse Event Report: WESTMED, INC. BAGEASY RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 562048

Device Problems Detachment of Device or Device Component (2907); Gas/Air Leak (2946); Physical Resistance/Sticking (4012)

Patient Problem Dyspnea (1816)

Event Date 03/24/2023

Event Type  Injury  

Event Description

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 emergency room 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.Product information: manufacturer product number: 562048, manufactured by: westmed.

• Brand Name: BAGEASY RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 16662745
• MDR Text Key: 312532479
• Report Number: 16662745
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 562048
• Device Catalogue Number: 562048
• Device Lot Number: 071122U10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2023
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization