FDA Adverse Event
Malfunction
Summary report: N
NATUS PHOTIC STIM KIT
MDR report key: 8074454
·
Received November 15, 2018
Report
- Report Number
- 9612330-2018-00018
- Event Type
- Malfunction
- Date Received
- November 15, 2018
- Date of Event
- February 13, 2016
- Report Date
- February 13, 2016
- Manufacturer
- NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK)
- Product Code
- GWE
- PMA / PMN Number
- K173936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FOLLOWING NATUS COMPLAINT PROCEDURE, THE PHOTIC SYSTEM WAS INVESTIGATED. THE CABLE FOUND BROKEN AT THE END OF LOWER ARM. NORMAL WEAR AND TEAR FAILURE DUE TO MECHANICAL MOVEMENT.
Description of Event or Problem · 1
DURING PHOTIC ACTIVATION THE POWER CABLE STARTING SPARKING. PHOTIC POWER CABLE HAD EXPOSED WIRES AFTER SPARKS OCCURED. NO ONE WAS HURT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 913537 | NATUS PHOTIC STIM KIT | PHOTIC STIMULATOR | GWE | NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |