FDA Adverse Event
Malfunction
Summary report: N
POWER CORD - NORTH AMERICA
MDR report key: 6108780
·
Received November 17, 2016
Report
- Report Number
- 3010293992-2016-00251
- Event Type
- Malfunction
- Date Received
- November 17, 2016
- Date of Event
- October 21, 2016
- Report Date
- March 6, 2017
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- MRZ
- UDI-DI
- 07290109150055
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). EXEMPTION NUMBER, E2014005.
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): "IN OUR MATERNAL CHILD PROGRAM I HAVE NOW HAD A SECOND STAFF MEMBER SHOCKED WHEN THE HOUSING OF THE POWER SUPPLY HAS COME APART ON TRYING TO UNPLUG THE UNIT FROM THE WALL ELECTRICAL SUPPLY. OUR ELECTRICIAN CAME TO OUR UNIT TO UNPLUG FOR US AND WAS CONCERNED HOW EASILY THE UNITS ARE COMING APART AS AM I WITH CONTINUED HIGH VOLUME USAGE. THE NEWEST POWER SUPPLIES I REPLACED THE FIRST UNIT WITH IS MADE DIFFERENTLY UTILIZING SCREWS TO HOLD THE PRODUCT TOGETHER."
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): STAFF MEMBER RECEIVED ELECTRIC SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761067 | POWER CORD - NORTH AMERICA | POWER SUPPLY | MRZ | Q CORE MEDICAL LTD. | 07290109150055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |