FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2083200
·
Received April 13, 2011
Report
- Report Number
- 1218950-2011-01002
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Report Date
- March 17, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THE DEVICE DID NOT FUNCTION AS EXPECTED DURING SYNC CARDIOVERSION. THE HOSPITAL BIOMED EVALUATED THE DEVICE AND NO TROUBLE WAS FOUND. THE CUSTOMER WOULD LIKE THE DEVICE TO BE EVALUATED BY PHILIPS. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT. 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 THE DEVICE DID NOT FUNCTION AS EXPECTED DURING SYNC CARDIOVERSION.
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 |