MAUDE Adverse Event Report: ACCELERATED CARE PLUS CORP OMNISTIM 500 PRO; STIMULATOR, MUSCLE, POWERED

Model Number 100500C

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 03/28/2019

Event Type  malfunction  

Event Description

Patient had a small shock from equipment.Equipment was sequestered and retired because of age of unit.

• Brand Name: OMNISTIM 500 PRO
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): ACCELERATED CARE PLUS CORP; 4999 aircenter cir.; ste 103; reno NV 89502
• MDR Report Key: 8707008
• MDR Text Key: 148278872
• Report Number: 8707008
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100500C
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2019
• Date Report to Manufacturer: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other