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

Catalog Number 199003020

Device Problem Separation Problem (4043)

Patient Problem Respiratory Insufficiency (4462)

Event Date 03/04/2024

Event Type  Death  

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 "always visually inspect the product after unpacking, assembly and prior to use as defects and foreign matter can lead to no or reduced peep during ventilation of the patient" and "be careful not to unscrew the adjustment cap as it can detach.If this happens the cap can be reattached again".This mdr address the secondproduct malfunctions reported for this incident (issue #2).The first product malfunction (issue #1) reported during this incident is reported in mdr 1220828-2024-0003.

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 mdr 1220828-2024-00003).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 this mdr).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 "always visually inspect the product after unpacking, assembly and prior to use as defects and foreign matter can lead to no or reduced peep during ventilation of the patient" and "be careful not to unscrew the adjustment cap as it can detach.If this happens the cap can be reattached again".This mdr, 1220828-2024-0004, address the second product malfunctions reported for this incident (issue #2).The first product malfunction (issue #1) reported during this incident is reported in mdr 1220828-2024-0003.06/07/2024 - follow-up #1 on may 9th, 2024 ambu received additional information from the customer on the second product malfunction reported (issue #2).The customer informed that the adjustment caps detached from the body of the valve when the valve was tightened to 20 cm h2o, and therefore not during the act of reducing the expiratory pressure where the valve tension is released, which eventually will make the adjustment cap to detach from the valve.Based on this information the complaint investigation has been updated accordingly.The adjustment cap is per design connected to the housing of the peep valve by thread engagement.During manufacturing a scale accuracy test is performed to verify that the adjustment cap allows for adjustment in the entire range for pressure setpoint without separating from the housing during normal use.Furthermore, the adjustment cap is adjusted from scale value 0 cm h2o to 20 cm h2o, to measure the pressure and perform a leakage test as specified in the product control procedure.No abnormalities were identified in the manufacturing records or production records which could lead to this failure, why the device should be within specifications when released from manufacturer.The failure can arise from different causes, such as the adjustment cap damaged after delivery or thread slipped.It has not been possible to further investigate this as the affected devices were discarded and based on the limited information available.The failure could still not be verified, and no root cause could be established.This is the first complaint received for disposable peep valve reporting the product failure, adjustment cap came off completely.The failure is covered by the current risk management documentation and considered acceptable.

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 mdr 1220828-2024-00003).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 this 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.

• 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, dnk 2750 ; DA 2750
• MDR Report Key: 19037912
• MDR Text Key: 339319113
• Report Number: 1220828-2024-00004
• 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: 04/03/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death