FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2150347
·
Received June 7, 2011
Report
- Report Number
- 1218950-2011-01591
- Event Type
- Malfunction
- Date Received
- June 7, 2011
- Report Date
- May 10, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT WHEN THEY TURNED THE ENERGY SELECT SWITCH, THE DEVICE DID NOT TURN ON. THE CUSTOMER REPORTED THAT THIS OCCURRED WHILE EXECUTING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THEY TURNED THE ENERGY SELECT SWITCH, THE DEVICE DID NOT TURN ON. THE CUSTOMER REPORTED THAT THIS OCCURRED WHILE EXECUTING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
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 |