FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 3122640
·
Received May 17, 2013
Report
- Report Number
- 1218950-2013-01878
- Event Type
- Malfunction
- Date Received
- May 17, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 15, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO RECOGNIZE THE PADS ECG WITH FIRST 2 SETS OF PADS DURING A RESUSCITATION. A THIRD SET USED ON THE SAME DEVICE WORKED. THE INVOLVED PATIENT DIED. THERE IS NOT INFORMATION AT THIS TIME REGARDING THE IMPACT OF THE DEVICE BEHAVIOR ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND THE INVESTIGATION REMAINS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219027 | HEART START XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |