FDA Adverse Event
Malfunction
Summary report: N
POWER SUPPLY (FIXED HEADS )
MDR report key: 5400999
·
Received January 31, 2016
Report
- Report Number
- 3010293992-2016-00030
- Event Type
- Malfunction
- Date Received
- January 31, 2016
- Report Date
- January 6, 2016
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- MRZ
- PMA / PMN Number
- K123049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). EXEMPTION NUMBER, E2014005.
Additional Manufacturer Narrative · 0
DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER, SAN JOSE, CA 95138. EXEMPTION NUMBER: E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "THE OTHER FIVE (LOT # 0915) ARE DAMAGED AT THE END THAT CONNECTS TO THE 120V OUTLET (MOSTLY THE PLASTIC HOUSING CAME APART. ONE HAS THE BLACK AND WHITE WIRES PULLED OUT FROM THE PLASTIC HOUSING). DELAY IN THERAPY: UNKNOWN. NEED FOR MEDICAL INTERVENTION: UNKNOWN. "
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: PLASTIC HOUSING OF ADAPTORS CAME APART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59358 | POWER SUPPLY (FIXED HEADS ) | POWER SUPPLY (FIXED HEADS ) | MRZ | Q CORE MEDICAL LTD. | 0915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |