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

Catalog Number 20421

Device Problems Component Missing (2306); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2018

Event Type  malfunction  

Event Description

Premature baby delivered and nurse went to place transwarmer infant transport warmer.When opened from box nurse noticed there was no metal disc in the warmer that activates the heat.Product removed and new one used.

• 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: 8178454
• MDR Text Key: 130780739
• Report Number: 8178454
• 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: 11/21/2018,11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 20421
• Device Lot Number: IK147
• 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: 11/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1