FDA Adverse Event
Malfunction
Summary report: N
POWER SUPPLY (FIXED HEADS )
MDR report key: 5362642
·
Received January 13, 2016
Report
- Report Number
- 3010293992-2016-00011
- Event Type
- Malfunction
- Date Received
- January 13, 2016
- Date of Event
- December 10, 2015
- Report Date
- December 12, 2015
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- MRZ
- PMA / PMN Number
- K123049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA. EXEMPTION NUMBER, E2014005.
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "THE POWER CORD ADAPTER (IMG 0303) HAS TOTALLY SEPARATED INTO TWO PARTS AND NEEDS A REPLACEMENT. THE POWER CORD (IMG 0305) MALE CONNECTOR END THAT PLUGS INTO THE PUMP IS COMPLETELY BROKEN AND NEEDS A REPLACEMENT AS WELL. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO. PATIENT INVOLVEMENT: NO. DEATH / SERIOUS INJURY: NO. HUMAN HARM: NO. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23102 | POWER SUPPLY (FIXED HEADS ) | POWER SUPPLY (FIXED HEADS ) | MRZ | Q CORE MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |