MAUDE Adverse Event Report: AIRLIFE VITAL SIGNS; VITAL SIGNS BABY SAFE FLOW-INFLATING RESUSCITATION

Model Number	54039VS
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, while preparing to transfer the patient to the nicu, a flow inflating resuscitation (fir) device was connected to the oxygen tank.Upon activation, the patient began to desaturate.The anesthesiologist observed that the device was leaking oxygen through a hole, resulting in ineffective oxygen delivery.The anesthesiologist promptly reconnected the anesthesia machine, provided appropriate oxygen, and stabilized the patient.A new fir device was then obtained and connected, allowing the team to proceed with the transfer.No serious harm or injury was reported as a result of this event.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): 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 (b)(6) 2026 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 airlife represents all of the information known 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 provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and 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 an airlife product is defective, caused, or contributed to a serious injury.

• Brand Name: VITAL SIGNS
• Common Device Name: VITAL SIGNS BABY SAFE FLOW-INFLATING RESUSCITATION
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr. nw, suite; grand rapids MI 49544
• Manufacturer (Section G): SALTER LABS DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167 parq; ind. las americas; horizonte s; juarez, 32596 ; MX 32596
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 24776337
• Report Number: 1314417-2026-00016
• Device Sequence Number: 18623264
• Product Code: BZD
• UDI-Device Identifier: 10889483585825
• UDI-Public: (01)10889483585825(10)0004337568(11)251024
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K911465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 54039VS
• Device Catalogue Number: 54039VS
• Device Lot Number: 0004337568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2025
• 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