MAUDE Adverse Event Report: DJO, LLC DONJOY ICEMAN CLASSIC; SYSTEM, ISOKINETIC TESTING AND EVALUATION

Model Number 1100

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

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

Event Date 11/06/2015

Event Type  malfunction  

Event Description

The pt was given a donjoy cryo-cuff and cooler for postoperative care following surgery.At follow up appointment, the pt reported that cryo-cuff cooler was not pumping iced water, and that motor was hot.

• Brand Name: DONJOY ICEMAN CLASSIC
• Type of Device: SYSTEM, ISOKINETIC TESTING AND EVALUATION
• Manufacturer (Section D): DJO, LLC; 1430 decision street,; vista CA 92081
• MDR Report Key: 5343070
• MDR Text Key: 35011665
• Report Number: 5343070
• Device Sequence Number: 1
• Product Code: IKK
• 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: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1100
• Device Lot Number: 092215-01M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1