MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; CURAPLEX SMALL ADULT/PED PREMIUM BVM W/ BAG RESERVOIR, MAN, 25CM POP-OFF, FILTER

Model Number 2442-BVMPSA

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The disk on the bottom that acts as a one-way valve came loose and was found in the bag.This caused a lack of positive pressure resulting in a delay of resuscitation efforts for the patient.The patient is in critical care on a ventilator currently.The failure was noted quickly, and a replacement was used from a backup on the ambulance.

Event Description

The disk on the bottom that acts as a one-way valve came loose and was found in the bag.Failure was on an ambulance.The unit failure resulted in lack of positive pressure.The airway emt noticed this and changed to another unit that in fact operated correctly.The etco2 improvement was dramatic.

• Brand Name: CURAPLEX
• Type of Device: CURAPLEX SMALL ADULT/PED PREMIUM BVM W/ BAG RESERVOIR, MAN, 25CM POP-OFF, FILTER
• 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: 18377722
• MDR Text Key: 331380613
• Report Number: 1314417-2023-00030
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 00812277037029
• UDI-Public: 00812277037029
• 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
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2442-BVMPSA
• Device Catalogue Number: 2442-BVMPSA
• Device Lot Number: 363395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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