MAUDE Adverse Event Report: WESTMED LLC BAGEASY; ADULT BAGEASY RESUSCITATOR W/PEEP AND MASK

Model Number	562048
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): manual resuscitation bag.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 23 jan 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.
Event or Problem Description
The reported issue: "when my staff went to use the ambu bag, they were unable to squeeze it.It was like there was an obstruction not allowing the bag to be squeezed.Later staff squeezed it as hard as they could and heard a "pop." then they were able to squeeze the bag normally.When kristie and i took the bag apart to inspect it we found a plastic valve right where the device connects to the airway.You could tell the plastic was ripped from where it popped when the staff squeezed the bag really hard.It appears the valve was sealed shut instead of opening like it should have." this has been documented as single event for the device, therefore only one mdr will be submitted.
Event or Problem Description
The reported issue: "when my staff went to use the ambu bag, they were unable to squeeze it.It was like there was an obstruction not allowing the bag to be squeezed.Later staff squeezed it as hard as they could and heard a "pop." then they were able to squeeze the bag normally.When kristie and i took the bag apart to inspect it we found a plastic valve right where the device connects to the airway.You could tell the plastic was ripped from where it popped when the staff squeezed the bag really hard.It appears the valve was sealed shut instead of opening like it should have." this has been documented as single event for the device, therefore only one mdr will be submitted.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): manual resuscitation bag.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 23 jan 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.The complaint of "it was like there was an obstruction not allowing the bag to be squeezed" regarding part 562048 was not confirmed.The root cause was not determined but could possibly be a result of mfg error - patient valve (duckbill) does not open.A risk assessment was performed and the ultimate risk was determined to be medium which does require escalation to the capa review board.There has been 1 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

• Brand Name: BAGEASY
• Common Device Name: ADULT BAGEASY RESUSCITATOR W/PEEP AND MASK
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED JAVID DE MEXICO, S.A. DE C.V; carretera internacional km 6.5; edif 18; parque industrial nog; nogales sonora, mexico 84094 ; MX 84094
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21225444
• Report Number: 2028807-2025-00001
• Device Sequence Number: 18214104
• Product Code: BTM
• UDI-Device Identifier: 00709078620485
• UDI-Public: (01)00709078620485(10)443080
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K934310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 562048
• Device Catalogue Number: 562048
• Device Lot Number: 443080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown