MAUDE Adverse Event Report: AMBU A/S PEEP VALVE 20/ADPT.DISP. 20PCS

Catalog Number 199003020

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Respiratory Insufficiency (4462)

Event Date 03/04/2024

Event Type  Death  

Event Description

The patient required bag ventilation for a considerable time due to low oxygen saturation.During this time the rt's involved had several issues with the peep valves.Issue #1: the therapist noticed that after a short time of use the valve was sticking and not allowing for any exhalation.There were using 20 cmh2o and noticed the valve was not working after it became slightly wet.They would have to take the valve off and could audibly hear the patient exhale because of the trapped gas/air from the valves not working.(issue #1 is reported in this mdr).Issue #2: when they dialed the valve down to 20 and would give the patient a breath; some of the valves red cap come off the completely.(issue #2 is reported in mdr 1220828-2024-00004).They went through 8-10 of these valves during the 2-3 hours of manually ventilating the patient.They didn't save the valves after the patient passed away.

Manufacturer Narrative

No sample could be returned for investigation as the customer disposed the item.Ambu a/s has through several attemps tried to follow-up with the customer to clarify whether the death of the patient was caused by or related to the reported product failure, and to get more information on the event.Unfortunately, that customer has not returned with a reply until this date.During manufacturing process all peep valves are function tested to ensure they meet design specification after assembling according to product control procedure.After review of the manufacturing records, no abnormalities which could cause the reported failure were identified.The product should be within specifications.As it has not been possible to receive more details and information on the event, the specific failure mode could not be determined.Therefore further investigation could not be performed.The root cause could not be determined.The instruction for use states " do not use ambu disposable peep 20 valve if visilbe moisture or residues are left inside the device in order to aviod the risk of infection or malfunction" and "always use the ambu disposable peep 20 valve with a manometer as the manometer ensures correct adjustment of the peep during ventilation.Too high or low peep during ventilation may cause barotrauma or hypoxia, respectively".This mdr, address one of the product malfunctions reported for this incident (issue #1).The second product malfunction (issue #2) reported during this incident is reported in mdr 1220828-2024-00004.

• Brand Name: PEEP VALVE 20/ADPT.DISP. 20PCS
• Type of Device: PEEP VALVE 20/ADPT.DISP. 20PCS
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• MDR Report Key: 19048034
• MDR Text Key: 339430171
• Report Number: 1220828-2024-00003
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/05/2024,04/03/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 199003020
• Device Lot Number: 1000892172
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death