MAUDE Adverse Event Report: Ambu A/S SPUR II Adult PLV Md FM Filter Mano PEEP Valve; Manual resuscitator

Catalog Number	523611051
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As per customer: appliation: ventilating intubated patient.Emergency pressure release valve came out of housing, separating completely from bmv unit, unable to generate positive pressure to ventilate patient.Patient outcome unknown.
Additional Manufacturer Narrative
As there is no information on whether a back-up device was promptly acquired and if ventilation was immediate restored and the further patient outcome, this complaint is reported as a serious injury because we are in doubt.The actual sample, pictures or lot number has not yet been provided.Several follow-ups have been done the customer without any feedback yet.The investigation is still on-going.A follow-up mdr will be submitted when investigation of the incident has been concluded.

• Brand Name: SPUR II Adult PLV Md FM Filter Mano PEEP Valve
• Common Device Name: Manual resuscitator
• Manufacturer (Section D): Ambu A/S; baltoprbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): Ambu Limited; no. c, warehouse & process; complex building xiang yu ft.z; xiamen, fujian province 36100 6; CH 361006
• Manufacturer Contact: bolette walldorf ; baltropbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 50096870
• Report Number: 9610691-2026-00025
• Device Sequence Number: 18733950
• Product Code: OEV
• UDI-Device Identifier: 05707480149513
• UDI-Public: 05707480149513
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 523611051
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/31/2026
• 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