FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2212815
·
Received July 12, 2011
Report
- Report Number
- 1218950-2011-01995
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Report Date
- June 16, 2011
- Manufacturer
- AGILENTTECHNOLOGIES
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE UNIT IS FAILING THE EARTH LEAKAGE CURRENT SAFETY TEST. THIS TESTING IS CONDUCTED WHEN THE DEVICE HAS BEEN REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER REPORTED THAT THEY ORDERED AND REPLACED THE POWER SUPPLY WHICH RESOLVED THIS ISSUE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE UNIT IS FAILING THE EARTH LEAKAGE CURRENT SAFETY TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | AGILENTTECHNOLOGIES | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |