MAUDE Adverse Event Report: DJO, LLC INTELECT MOBILE INT'L STD.; STIMULATOR, ULTRASOUND AND MUSCLE...

Model Number 2776

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: unknown.

Event Description

It was reported that the power supply has burned.There was no patient involvement reported.

Manufacturer Narrative

The device was returned for evaluation.It was inspected and the complaint could not be confirmed.

• Brand Name: INTELECT MOBILE INT'L STD.
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE...
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8264068
• MDR Text Key: 133771237
• Report Number: 2020737-2019-00001
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• PMA/PMN Number: K911733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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: Health Professional
• Device Model Number: 2776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 12/28/2018
• Supplement Dates FDA Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1