FDA Adverse Event
Malfunction
Summary report: N
POWER SUPPLY
MDR report key: 5400997
·
Received January 31, 2016
Report
- Report Number
- 3010293992-2016-00029
- Event Type
- Malfunction
- Date Received
- January 31, 2016
- Report Date
- December 30, 2015
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- MRZ
- PMA / PMN Number
- K123049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- 003
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: "AC ADAPTERS ARE BREAKING OFF AT THE WALL. DELAY IN THERAPY:NO. NEED FOR MEDICAL INTERVENTION:NO. PATIENT INVOLVEMENT: NO. DEATH / SERIOUS INJURY: NO. HUMAN HARM: NO. "
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "AC ADAPTERS ARE BREAKING OFF AT THE WALL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59344 | POWER SUPPLY | POWER SUPPLY | MRZ | Q CORE MEDICAL LTD. | 16312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |