N
Patient 1
MAUDE MDR 8388284
- MDR report key
- 8388284
- Report number
- 3030677-2019-00440
- Event key
- 0
- Event type
- 3
- Date received
- 2019-03-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. DANA TACKETT
- Address
- 22100 BOTHELL EVERETT HWY BOTHELL WA 98021 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NA | NA | PHILIPS MEDICAL SYSTEMS | MLN | NA | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-04 | 0 |
Event Narratives#
D
Patient 1
IT HAS BEEN REPORTED THAT THE PHILIPS BRAND PADS THAT WERE USED WITH A NON-PHILIPS DEFIBRILLATOR BURNED A PATIENT DURING A PATIENT USE EVENT. THE PATIENT OUTCOME IS UNKNOWN.
N
Patient 1
PLEASE NOTE, THIS WAS NOT A 5 DAY REPORT.
N
Patient 1
D
Patient 1
NEW INFORMATION FROM THE USER CONFIRMED THE PATIENT SURVIVED. IT HAS BEEN REPORTED THAT THE PHILIPS BRAND PADS THAT WERE USED WITH A NON-PHILIPS DEFIBRILLATOR BURNED A PATIENT DURING A PATIENT USE EVENT. THE PATIENT OUTCOME IS UNKNOWN.
N
Patient 1
.