D
Patient 1
PATIENT STATED THAT WHEN THE DEVICE WAS TURNED ON, IT FELT LIKE IT WAS BURNING AND SHOCKING HIM.
MAUDE MDR 1403891
- MDR report key
- 1403891
- Report number
- 1723686-2009-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-03-31
- Date received
- 2009-06-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 8022 SOUTHPARK CIRCLE,UNIT 100 LITTLETON CO 80120 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZYNEX | INTERFERENTIAL ELECTRICAL STIMULATOR | ZYNEX MEDICAL | LIH | IF 8000 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-06-16 | 0 | 1. O |
Event Narratives#
N
Patient 1
THIS IS BEING REPORTED AT THE RECOMMENDATION OF (B)(6) , FDA INVESTIGATOR AFTER AN INSPECTION OF ZYNEX MEDICAL ON 6/3/09-6/10/09. CONCLUSION: 6/9/08. PCB INSPECTED, TESTED AND REWORKED BY (B)(4) . REMOVED Q31. PADS FOR PINS 1 AND 2 HAD DISINTEGRATED AND COULD NOT BE SALVAGED. SOLDERED IN NEW (B)(4) (ONLY PIN 3). REMOVED Q30, (B)(4) AND REPLACED IT WITH (B)(4) . SOLDERED IN SHORT, 30 AWG JUMPERS BETWEEN Q31-2 AND Q30-2, AND BETWEEN Q31-1 AND Q30-3. BURNED IN FOR 60 MINUTES USING 12 VDC SUPPLY CONNECTED TO AC ADAPTER JACK. STARTING CURRENT DRAW WAS 400 MA. OUTPUT WAS 42 V PEAK. ENDING CURRENT DRAW WAS 36- MA. TESTED ELECTRODE ALARM AT 4, 20 AND 50 MA. WOULD ONLY WORK AT 4 MA. IMPLEMENTED BALANCE OF ECO 1023. NOTE: (B)(4) SWAP OUT WITH (B)(4) WAS PART OF ECO 1023. QUICK TEST OF CURRENT DRAW AND ELECTRODE ALARM CAPABILITY DID NOT REVEAL ANY SIGNIFICANT CHANGE. REASSEMBLED UNIT. UNIT RELEASED TO THE REPAIR AREA FOR PROCESSING INTO THE USED INVENTORY. CORRECTIVE ACTION: UNIT WILL BE UPDATED PER ECO 1023. NEW REV OF BOARD THAT IS IN THE TEST AND PROTOTYPE PHASE, WILL ELIMINATE THIS PROBLEM FROM OCCURRING.