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

Catalog Number UNK_MED

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

The customer elected to perform their own evaluation and found that the unit performed to specification.No defect was found.The customer elected to perform their own evaluation.

Event Description

It was reported that the patient was burned while being treated with the temperature pump.No details were given regarding the severity of the burns, or if medical intervention was required.The user did not allege any defects with the unit, and upon evaluation by the user, the unit passed all functional checks.

Manufacturer Narrative

A review of the information for this alleged event identified that unless there was a specific product malfunction, the burn was likely misidentified.For a burn to occur, the product 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.As such, 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 mul-t pad.

Event Description

It was reported that the patient received a soft-tissue injury.This can be attributed to mechanical forces (such as pressure or sheer) created by the mul-t pad.

• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6869390
• MDR Text Key: 86333043
• Report Number: 0001831750-2017-00399
• 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
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2002
• 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