FDA Adverse Event
Malfunction
Summary report: N
POWER SUPPLY
MDR report key: 5949134
·
Received September 14, 2016
Report
- Report Number
- 3010293992-2016-00196
- Event Type
- Malfunction
- Date Received
- September 14, 2016
- Date of Event
- August 15, 2016
- Report Date
- September 12, 2016
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- MRZ
- PMA / PMN Number
- K123049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). EXEMPTION NUMBER, E2014005.
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "NURSE RECEIVED A SHOCK WHILE UNPLUGGING A POWER CORD. KINDLY ACKNOWLEDGE IF HUMAN HARM CAUSED. PLEASE PROVIDE FULL DETAILS ABOUT THE INJURY. NO. PLEASE DETERMINE THE POWER SUPPLY CATALOG NUMBER, FOR EXAMPLE: 15072-000-0005, 15072-000-0007, 15072-000-0009 OR 05020-150-0160. (THE NUMBER APPEARS ON THE POWER SUPPLY CORD LABEL.) POWER SUPPLY DISPOSED OF. PLEASE PROVIDE THE POWER SUPPLY LOT NUMBER (APPEARS ON THE POWER SUPPLY CORD LABEL).N/A. HAS THE POWER SUPPLY BEEN USED BEFORE THIS EVENT? DID IT FUNCTION PROPERLY? YES. IS THERE ANY VISIBLE DAMAGE TO THE DEVICE? PLEASE SEND US A PHOTO IF POSSIBLE .YES, THE CHARGER WAS BROKEN IN HALF ALONG MOLDING SEAM. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601493 | POWER SUPPLY | POWER SUPPLY | MRZ | Q CORE MEDICAL LTD. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |