FDA Adverse Event
Malfunction
Summary report: N
KANGAROO EPUMP - INTERNATIONAL
MDR report key: 2910694
·
Received December 4, 2012
Report
- Report Number
- 1717344-2012-01199
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Report Date
- November 15, 2012
- Manufacturer
- COVIDIEN
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2012 THAT A CUSTOMER HAD AN ISSUE WITH THE POWER CORD OF A KANGAROO E-PUMP. THE CUSTOMER REPORTED THAT THE E-PUMP POWERPACK HAD ARCING. IT WAS NOTED THAT THERE WAS MELTING ON BOTH SIDES OF THE ADAPTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KANGAROO EPUMP - INTERNATIONAL | POWER CORD | JOW | COVIDIEN | 482400S | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |