MAUDE Adverse Event Report: MEDLINE INC. ACCU-THERM; PACK, HOT OR COLD, DISPOSABLE

Model Number MDS139005

Device Problems Melted (1385); Overheating of Device (1437)

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

Event Date 01/30/2018

Event Type  malfunction  

Event Description

Pack was activated and got so hot it melted plastic.Cut the pack open to check temperature and thermometer errored out after 106°.

• Brand Name: ACCU-THERM
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7285377
• MDR Text Key: 100643954
• Report Number: 7285377
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: MDS139005
• Device Lot Number: CN17315
• Other Device ID Number: 0110080196158669
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1