MAUDE Adverse Event Report: AMBU A/S SPUR II ADULT PLV MD FM FILTER MANO PEEP VALVE; SPUR II RESUSCITATOR

Model Number	523611051
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was involved, however we were unable to obtain any information on patient condition.The customer reported leaking around the pop off valve when in use, even at low pressures.This has been an ongoing issue for months and the customer reported it as an intermittent issue.
Additional Manufacturer Narrative
The reported failure could not be verified, since neither the affected sample, nor pictures were returned for investigation.The spur ii is designed with pressure limiting valve (plv) and an override clip which is in line with ds/en iso 10651-4:2009.The plv opens naturally and releases air to ambient, if pressure to patient is above setpoint for the valve (40 cm h20).During manufacturing, pressure limiting test is performed, as well as high/low pressure test of the whole spur ii.During these test, leaking would be detected.Review of production records did not reveal any abnormality.Possible causes of air leaking from plv are: damage to the plv during transportation or storage, plv not assembled well, or air releasing naturally at pressure greater than 40 cm h20.However, due to limited information from the customer, the specific failure mode and root cause are unknown.The failure has been identified in risk management file.The ifu states: 'always inspect the resuscitator and accessories (e.G.Face mask, peep valve, filters, etc.) and perform a functional test after unpacking, cleaning, assembly and prior to use.' ; 'if the resuscitator is equipped with a pressure limiting valve, the valve is set to open at 40 cmh2o (4.0 kpa)', and 'if medical and professional assessment indicates a pressure above 40 cmh2o is required pressure limiting valve can be overwritten by pressing the override clip onto the valve.Alternatively the pressure limiting valve can be overwritten by placing the index finger on the red button while squeezing the bag.'.We will keep monitoring the market for similar incidents.

• Brand Name: SPUR II ADULT PLV MD FM FILTER MANO PEEP VALVE
• Common Device Name: SPUR II RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU LTD.; complex building, no. c; xiang yu f.t.z.; xiamen, 36100 6; CH 361006
• Manufacturer Contact: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 20682199
• Report Number: 9610691-2024-00020
• Device Sequence Number: 7281447
• Product Code: OEV
• UDI-Device Identifier: 05707480149513
• UDI-Public: 05707480149513
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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 Expiration Date: 07/18/2026
• Device Model Number: 523611051
• Device Catalogue Number: 523611051
• Device Lot Number: 2000011124
• 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: 10/17/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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
• Patient Sex: Unknown