FDA Adverse Event
Death
Summary report: N
HEART START XL
MDR report key: 2081664
·
Received April 26, 2011
Report
- Report Number
- 1218950-2011-01139
- Event Type
- Death
- Date Received
- April 26, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 29, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT ALARM AS EXPECTED DURING PATIENT EVENT AND THAT THE INVOLVED PATIENT DIED. AT THIS TIME, THERE HAS BEEN NO DETERMINATION AS TO WHETHER THE DEVICE WAS A FACTOR IN THE REPORTED DEATH OF THE PATIENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE DID NOT ALARM AS EXPECTED DURING PATIENT EVENT AND THAT THE INVOLVED PATIENT DIED.
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 |