MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT MOBILE COMBO, INT'L STD, 5CM APPL; STIMULATOR, MUSCLE, POWERED

Model Number 2778

Device Problem Intermittent Energy Output (4025)

Patient Problem Electric Shock (2554)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the intensity goes up on its own and cannot be controlled; it gets very high and shocked a patient.No further information is currently available.

Manufacturer Narrative

Investigation revealed a defective ultrasound probe cable and rubber body separating.Parts were replaced and applicator was calibrated.Cleaned up unit, contacts, and re-seated boards.Full functional test was ran.

• Brand Name: CHATTANOOGA INTELECT MOBILE COMBO, INT'L STD, 5CM APPL
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9864812
• MDR Text Key: 184492113
• Report Number: 9616086-2020-00012
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• PMA/PMN Number: K973024
• 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: 03/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2778
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1