MAUDE Adverse Event Report: VENTLAB LLC VENTLAB; INFANT SAFE SPOT W/MANOMETER, MASK,BAG RESERVOIR AND STICKER

Model Number	SS3200MB-MMC
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reorted that when staff opened the packaging for pediatric bvm the ambu bag malfunctioned- valve broke off.Reports pediatric patient was in respiratory distress.When staff opened the packaging for pediatric bvm the ambu bag malfunctioned- valve broke off, resulting in inability to ventilate patient.Used a larger product and patient maintained patient safety.
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 10 april 2026 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 (b)(4).This informati on 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.

• Brand Name: VENTLAB
• Common Device Name: INFANT SAFE SPOT W/MANOMETER, MASK,BAG RESERVOIR AND STICKER
• Manufacturer (Section D): VENTLAB LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no. 85 parque indust.mexicali; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 24851037
• Report Number: 1314417-2026-00023
• Device Sequence Number: 15690121
• Product Code: BTM
• UDI-Device Identifier: 10889483105771
• UDI-Public: (01)10889483105771
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: SS3200MB-MMC
• Device Catalogue Number: SS3200MB-MMC
• Device Lot Number: UNKNOWN
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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