FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2910661
·
Received December 4, 2012
Report
- Report Number
- 1218950-2012-03996
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Report Date
- November 15, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED DEVICE WILL NOT ALWAYS BOOT. THE CUSTOMER'S BIOMED COULD NOT RECREATE THE ERROR. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND THE SYMPTOM COULD NOT BE DUPLICATED. THE DEVICE PASSED ALL TESTING. BASED ON THE CUSTOMER'S INITIAL COMPLAINT, WE ARE CONSIDERING THIS A MALFUNCTION. HOWEVER, WE CANNOT DETERMINE THE CAUSE SINCE THE SYMPTOM COULD NOT BE DUPLICATED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED DEVICE WILL NOT ALWAYS BOOT. THE CUSTOMER'S BIOMED COULD NOT RECREATE THE ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |