MAUDE Adverse Event Report: SUNMED HOLDINGS LLC AIRFLOW; AIRFLOW PEDIATRIC RESUSCITATOR WITH INTEGRATED MANOMETER, B/V FILTER, 40CM POP-O

Model Number	AF2142MBS-45E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the airflow pediatric resuscitator mask being oval-shaped, making it difficult to connect to the bvm, is a reportable incident.This issue occurs during emergency situations, leading to delays in oxygen delivery due to the misshapen connection.Such delays could result in serious harm or injury if the patient does not receive oxygen quickly enough.
Additional Manufacturer Narrative
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 25 mar 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.
Additional Manufacturer Narrative
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 25 mar 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 "the bvm mask hub is shaped like an oval" regarding part af2142mbs-45e was confirmed.The root cause was determined to originate from the supplier and was not caught during incoming inspection.A risk assessment was performed, and the ultimate risk was determined to be medium which does not require escalation to the capa review board.There have been 0 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.
Event or Problem Description
It has been reported that the airflow pediatric resuscitator mask being oval-shaped, making it difficult to connect to the bvm, is a reportable incident.This issue occurs during emergency situations, leading to delays in oxygen delivery due to the misshapen connection.Such delays could result in serious harm or injury if the patient does not receive oxygen quickly enough.

• Brand Name: AIRFLOW
• Common Device Name: AIRFLOW PEDIATRIC RESUSCITATOR WITH INTEGRATED MANOMETER, B/V FILTER, 40CM POP-O
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, china 51917 0; CH 519170
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21692355
• Report Number: 1314417-2025-00014
• Device Sequence Number: 9419817
• Product Code: BTM
• UDI-Device Identifier: 10889483565643
• UDI-Public: (01)10889483565643(10)490870
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: AF2142MBS-45E
• Device Catalogue Number: N/A
• Device Lot Number: 490870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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