FDA Adverse Event
Death
Summary report: N
HEART START XL
MDR report key: 2234151
·
Received August 31, 2011
Report
- Report Number
- 1218950-2011-02581
- Event Type
- Death
- Date Received
- August 31, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 26, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS CUSTOMER REPORTED THAT THEY GOT MULTIPLE "NO SHOCK DELIVERED" MESSAGES DURING A RESUSCITATION ATTEMPT. THE INVOLVED PATIENT DIED HOWEVER THE RELATIONSHIP OF THE DEVICE TO THE PATIENT OUTCOME HAS NOT YET BEEN DETERMINED. 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
THIS CUSTOMER REPORTED THAT THEY GOT MULTIPLE "NO SHOCK DELIVERED" MESSAGES DURING A RESUSCITATION ATTEMPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | PHILIPS HEALTHCARE - ANDOVER | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |