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

Model Number 20421

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 01/02/2021

Event Type  malfunction  

Event Description

Transwarmer infant transport mattress was activated before use inside the box.Jelly was already white rather than clear when opened and would not heat up.

• Brand Name: TRANSWARMER INFANT TRANSPORT MATTRESS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): COOPERSURGICAL, INC; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 11116251
• MDR Text Key: 241251563
• Report Number: 11116251
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IK674
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Weight: 2