MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; MRI PEEP W/ ADAPTOR

Model Number 301-MRIPEEP-A

Device Problem Material Integrity Problem (2978)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

The resuscitation bag was being used with the peep valve that could have been blocked, which would have delayed treatment.

Event 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 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.

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.

• Brand Name: CURAPLEX
• Type of Device: MRI PEEP W/ ADAPTOR
• 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
• MDR Text Key: 330971836
• Report Number: 1314417-2023-00029
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 301-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
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other