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

Model Number 562048

Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907); Gas/Air Leak (2946); Physical Resistance/Sticking (4012); Failure to Seal (4070)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/24/2023

Event Type  Death  

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 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.Product information: manufacturer product number: 562048; manufactured by: westmed.We have received numerous reports about same westbag ambubags failing due to a leak.Sites are reporting westmed ambubag failing putting patients in serious risk of death.Here is an example of one report: a patient almost died.An endotracheal tube was replaced with a new one, but the patient's condition worsened.Decision was made by the ent surgeon to perform an emergency tracheostomy.It was noted that the et tube was correctly placed, and the incision was closed.A crna noted that the ambu-bag was leaking, which led to the unplanned tracheostomy.The product is available for evaluation.Request fda take action to ensure manufacturer takes actions to improve design and quality of products.These devices are intended to save lives and not jeopardize and risk patients health and safety in critical circumstances.The various reports we have mention ambu bags leaking.The failure of the ambu-bag, which had an air leak, led to more prolonged hypoxia and the decision to perform an emergency tracheostomy.Patient's condition had deteriorated, and chest compressions and cardiac code medications were initiated.

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 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.Product information: manufacturer product number: 562048 manufactured by: westmed we have received numerous reports about same westbag ambubags failing due to a leak.Sites are reporting westmed ambubag failing putting patients in serious risk of death.Here is an example of one report: a patient almost died.An endotracheal tube was replaced with a new one, but the patient's condition worsened.Decision was made by the ent surgeon to perform an emergency tracheostomy.It was noted that the et tube was correctly placed, and the incision was closed.A crna noted that the ambu-bag was leaking, which led to the unplanned tracheostomy.The product is available for evaluation.Request fda take action to ensure manufacturer takes actions to improve design and quality of products.These devices are intended to save lives and not jeopardize and risk patients health and safety in critical circumstances.The various reports we have mention ambu bags leaking.The failure of the ambu-bag, which had an air leak, led to more prolonged hypoxia and the decision to perform an emergency tracheostomy.Patient's condition had deteriorated, and chest compressions and cardiac code medications were initiated.

• Brand Name: BAGEASY
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 16706707
• MDR Text Key: 313041136
• Report Number: 16706707
• 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,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Death; Required Intervention