MAUDE Adverse Event Report: DJO, LLC ICEMAN CLASSIC; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number 13-6294-0 REV D

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 08/05/2017

Event Type  malfunction  

Event Description

Patient had a l4-5 posterior lumbar interbody fusion with placement of percutaneous pedicle screws.Patient was using iceman classic in his patient room on his back to relieve pain.Rn heard a loud noise and heard patient yell out.She went into the patient's room to find the floor flooded with water; the pad to the machine had exploded.

• Brand Name: ICEMAN CLASSIC
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• MDR Report Key: 6841763
• MDR Text Key: 84851891
• Report Number: 6841763
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 13-6294-0 REV D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 77