MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number UNK_MED

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/27/2016

Event Type  Injury  

Event Description

It was alleged that a patient was burned while using the device.It was alleged that the heating pad was to hot for the patients back.

Manufacturer Narrative

The device passed evaluation and testing and the alleged issue could not be duplicated and no component level defect was identified.

Event Description

It was alleged that a patient was burned while using the device.It was alleged that the heating pad was to hot for the patients back.

Manufacturer Narrative

It was alleged that a patient was burned while using the device.It was alleged that the heating pad was to hot for the patients back.In response, the t-pump associated with this device was returned to stryker for evaluation by a stryker representative.The t-pump was subjected to a backup limit thermostat test as specified in the maintenance manual.The t-pump passed this test showing that there was no component level defect causing the t-pump to overheat and cause the alleged burn.It was identified that unless there was a specific product malfunction, the burn was likely misidentified.For a burn to occur, the t-pump would need to be at least 44°c.Without a failure of the backup and primary thermostats, the highest temperature the t-pump can reach is 42°c.It is likely that the injury was misidentified by the customer.This injury was most likely a soft-tissue injury.This can be attributed to mechanical forces (such as pressure or sheer) created by the pad.The report has been updated to represent the event being caused by the pad.

Event Description

It was alleged that a patient was burned while using the device.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5822691
• MDR Text Key: 50452395
• Report Number: 0001831750-2016-00238
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1