MAUDE Adverse Event Report: AIRLIFE AIR LIFE; DISPOSABLE HYPERINFLATION SYSTEM, 1/2 AMBU BAG

Model Number	900 000 614
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation a review of the device history record is in-progress.Analysis of the photographic evidence provided by the reporter is in progress.All information reasonably known as of 25 mar 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and identified as (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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the third of three reports.Refer to 2028807-2025-00009 for the first report.Refer to 2028807-2025-00010 for the second report.It was reported, the clear connector piece was installed incorrectly into the balloon which caused the neonatal mask not to fit properly and resulted in confusion during treatment and a delay in care as the healthcare professional had to disassemble and reassemble the inflation system in order to make it functional and or find one that was correctly assembled.There was no reported injury.
Additional Manufacturer Narrative
Correction: g1; d9.Additional information: h6.The actual complaint product was not returned for evaluation; however, photographic evidence was provided and was reviewed.The complaint was confirmed; however, the root cause could not be determined.The device history record for lot 512484 was reviewed and the product was produced according to product specifications.All information reasonably known as of 13 jun 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and identified as (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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the third of three reports.Refer to 2028807-2025-00009 for the first report.Refer to 2028807-2025-00010 for the second report.It was reported, the clear connector piece was installed incorrectly into the balloon which caused the neonatal mask not to fit properly and resulted in confusion during treatment and a delay in care as the healthcare professional had to disassemble and reassemble the inflation system in order to make it functional and or find one that was correctly assembled.There was no reported injury.

• Brand Name: AIR LIFE
• Common Device Name: DISPOSABLE HYPERINFLATION SYSTEM, 1/2 AMBU BAG
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 21692415
• Report Number: 2028807-2025-00011
• Device Sequence Number: 21159228
• Product Code: BZR
• UDI-Device Identifier: 05707480137527
• UDI-Public: (01)05707480137527(10)512484(17)250830(11)230830
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K932709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 900 000 614
• Device Lot Number: 512484
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown