FDA Adverse Event
Malfunction
Summary report: N
Q CORE POWER SUPPLY
MDR report key: 4976002
·
Received August 6, 2015
Report
- Report Number
- 3010293992-2015-00146
- Event Type
- Malfunction
- Date Received
- August 6, 2015
- Date of Event
- June 25, 2015
- Report Date
- June 26, 2015
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- MRZ
- PMA / PMN Number
- K123049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS REPORTING ON BEHALF OF HOSPIRA.
Description of Event or Problem · 1
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "WHEN PULLING POWER CORD FROM SOCKET THE PLASTIC ON PLUG BROKE. IT CAME APART RIGHT ON THE SEAM. CIRCUIT BOARD EXPOSED WITH WIRES. IT CAUSED A SLIGHT DELAY IN THERAPY SINCE THEY WERE NOT ABLE TO PUT IT ON A PATIENT IMMEDIATELY. DELAY IN THERAPY: YES. NEED FOR MEDICAL INTERVENTION: NO. HUMAN HARM: NO."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 519764 | Q CORE POWER SUPPLY | POWER SUPPLY | MRZ | Q CORE MEDICAL LTD. | 4814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |