FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2123527
·
Received June 9, 2011
Report
- Report Number
- 1218950-2011-01646
- Event Type
- Malfunction
- Date Received
- June 9, 2011
- Report Date
- May 20, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SHOCK AS EXPECTED DURING CARDIOVERSION. THERE WAS NO REPORT OF NEGATIVE PT IMPACT. THIS COMPLAINT IS STILL INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SHOCK AS EXPECTED DURING CARDIOVERSION. THERE WAS NO REPORT OF NEGATIVE PT IMPACT.
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 |