MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; PEEP VALVE,19MM,MRI,30MM ADAPTER 20/ CA CLOSE

Model Number	MRIPEEP-A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The resuscitation bag was being used with the peep valve that could have been blocked, which would have delayed treatment.
Event or Problem Description
Upon disconnecting pt from vent and manually bagging to icu.Within first couple breaths manually delivered, noticed peep valve was not making standard noise.Upon further assessment notice pts chest kept rising but not falling.Quickly disconnected from et tube and noted a huge rush of air released from et tube.One more time i reconnected bag and delivered two more breaths noting again no true exhale from pt/bag.Disconnected again and rush of air noted again.Quickly had pt returned to room and placed back on vent.Acquired new ambu bag and peep valve.New equipment worked properly and pt was safely delivered to new unit.
Event or Problem Description
Upon disconnecting pt from vent and manually bagging to icu.Within first couple breaths manually delivered, noticed peep valve was not making standard noise.Upon further assessment notice pts chest kept rising but not falling.Quickly disconnected from et tube and noted a huge rush of air released from et tube.One more time i reconnected bag and delivered two more breaths noting again no true exhale from pt/bag.Disconnected again and rush of air noted again.Quickly had pt returned to room and placed back on vent.Acquired new ambu bag and peep valve.New equipment worked properly and pt was safely delivered to new unit.
Additional Manufacturer Narrative
The resuscitation bag was being used with the peep valve that could have been blocked, which would have delayed treatment.The complaint of "peep valve not making standard noise.Pt not fully exhaling." regarding part 301-mripeep-a was not confirmed because functional testing indicated that the device formed as intended.The root cause cannot be determined but could possibly be a result of an issue with the resus bag that was used.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints against this part in the 24 months preceding this complaint.A resolution letter was sent to the customer.
Additional Manufacturer Narrative
The resuscitation bag was being used with the peep valve that could have been blocked, which would have delayed treatment.The complaint of "peep valve not making standard noise.Pt not fully exhaling." regarding part 301-mripeep-a was not confirmed because functional testing indicated that the device formed as intended.The root cause cannot be determined but could possibly be a result of an issue with the resus bag that was used.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints against this part in the 24 months preceding this complaint.A resolution letter was sent to the customer.**udi related data quality updates only.**.
Event or Problem Description
Upon disconnecting pt from vent and manually bagging to icu.Within first couple breaths manually delivered, noticed peep valve was not making standard noise.Upon further assessment notice pts chest kept rising but not falling.Quickly disconnected from et tube and noted a huge rush of air released from et tube.One more time i reconnected bag and delivered two more breaths noting again no true exhale from pt/bag.Disconnected again and rush of air noted again.Quickly had pt returned to room and placed back on vent.Acquired new ambu bag and peep valve.New equipment worked properly and pt was safely delivered to new unit.

• Brand Name: CURAPLEX
• Common Device Name: PEEP VALVE,19MM,MRI,30MM ADAPTER 20/ CA CLOSE
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC; 5000 tuttle crossing inc.; dublin OH 43016
• Manufacturer (Section G): BOUND TREE MEDICAL, LLC; 5000 tuttle crossing inc.; dublin OH 43016
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18326718
• Report Number: 1314417-2023-00029
• Device Sequence Number: 20661933
• Product Code: BYE
• UDI-Device Identifier: 00810071637278
• UDI-Public: (01)00810071637278
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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 Model Number: MRIPEEP-A
• Device Catalogue Number: 301-MRIPEEP-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 11/16/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/15/2024; 07/23/2024
• 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