FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2102341
·
Received May 18, 2011
Report
- Report Number
- 1218950-2011-01415
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Report Date
- April 22, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE DISPLAY ON THE DEVICE WAS BLANK. PHILIPS ASSISTED THE CUSTOMER OVER THE PHONE WITH LOCALIZING THE PROBLEM TO A BLOWN FUSE ON THE CONTROL PCA DUE TO A BAD KEYSCAN PCA. THE CUSTOMER ORDERED A REPLACEMENT CONTROL PCA AND KEYSCAN PCA. WE ARE CONSIDERING THIS A MALFUNCTION OF THE KEYSCAN PCA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DISPLAY ON THE DEVICE WAS BLANK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | PHILIPS HEALTHCARE | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |