MAUDE Adverse Event Report: GAYMAR-STRYKER T-PUMP

Model Number TP500

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 11/27/2013

Event Type  malfunction  

Event Description

Continuous heating unit caused burn to pt.Continuous heat therapy ordered for pt, found pt to have burns after having laied on heat source.

• Brand Name: T-PUMP
• Type of Device: T-PUMP
• Manufacturer (Section D): GAYMAR-STRYKER
• MDR Report Key: 3573273
• MDR Text Key: 19567738
• Report Number: MW5033816
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TP500
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR