MAUDE Adverse Event Report: COOPERSURGICAL, INC TRANSWARMER; PACK, HOT OR COLD, DISPOSABLE

Model Number 20421

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

Attempted to activate transwarmer infant transport mattress for rewarming of trauma patient.Mattress did not warm after multiple attempts to activate.

Event Description

Attempted to activate transwarmer infant transport mattress for rewarming of trauma patient.Mattress did not warm after multiple attempts to activate.

• Brand Name: TRANSWARMER
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): COOPERSURGICAL, INC; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 10945540
• MDR Text Key: 219502074
• Report Number: 10945540
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IK674
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Weight: 6