D
Patient 1
THE CUSTOMER REPORTED THAT THE BATTERY FAILS THE 3 HR HOLDING TEST. THERE WAS NO PT INVOLVEMENT.
MAUDE MDR 3970166
- MDR report key
- 3970166
- Report number
- 1218950-2014-02403
- Event key
- 0
- Event type
- 3
- Date received
- 2014-04-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- NANCY ATAIDE
- Address
- 3000 MINUTEMAN RD. ANDOVER MA 01810 US
- Phone
- 978-978-9786
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | PHILIPS MEDICAL SYSTEMS | MJK | M4735A | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-04-29 | 0 |
Event Narratives#
N
Patient 1
PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.