MAUDE Adverse Event Report: COMPASS HEALTH BRANDS (CORPORATE OFFICE) TENS 7000 RECHARGEABLE; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Model Number DT7303

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

Compass health brands of middleburg, oh makes a tens 7000 rechargeable medical device (item dt7303).The on/off button and start/stop button are one single button and that button frequently malfunctions leaving the unit either stuck in on or off mode with no way to alter it until the battery on the unit dies.I have experienced this multiple times.It is problematic when it is stuck in the off mode because then i can't use the device for many hours for treatment.It is more problematic when it is stuck in the on mode because i then have to remove the tens electrodes mid-usage which is painful and i fear it could be dangerous to me and to the unit.Pressing and holding the button normally shuts the device down, but often results in the screen going blank, but the backlight remaining on.At this point, none of the controls seem to have any effect on the unit, although it will still beep (what the beep signifies is not known, because the unit doesn't seem to act any differently).

• Brand Name: TENS 7000 RECHARGEABLE
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): COMPASS HEALTH BRANDS (CORPORATE OFFICE)
• MDR Report Key: 18704288
• MDR Text Key: 335461675
• Report Number: MW5151570
• Device Sequence Number: 1
• Product Code: NGX
• UDI-Device Identifier: 00092237623756
• UDI-Public: (01)00092237623756
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2024

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: Lay User/Patient
• Device Model Number: DT7303
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White