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

Catalog Number TP500

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the product met specifications as the product was not returned for evaluation.The t pump was outside of the expected service life and also being used in a veterinary environment in which it is not designed or sold for use.The issue may have occurred if the ground path was compromised on the unit which may expose the user to accessible electric voltage/current, this could not be confirmed.This report is being resubmitted because it is a correction of the original report that was inadvertently submitted as supplement instead of an initial report on 03/20/2018 for mfr # 0001831750-2018-00151.Mfr # 0001831750-2018-00151 never received ack 3 acknowledgment after multiple attempts, so this report is being submitted in its place.Device not returned of evaluation.

Event Description

It was reported that allegedly a technician experienced two shocks from the device on their finger while treating a patient.No medical intervention was reported for the user or patient.

• Brand Name: TEMP PUMP TEMPERATURE
• 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: 7608230
• MDR Text Key: 111861853
• Report Number: 0001831750-2018-00580
• 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
• Report Date: 06/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: TP500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2008
• 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