N
Patient 1
ZOLL HAS RECEIVED THE BATTERY HOWEVER, THE INVESTIGATION IS PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
MAUDE MDR 9709074
- MDR report key
- 9709074
- Report number
- 3010617000-2020-00141
- Event key
- 0
- Event type
- 3
- Date received
- 2020-02-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. KIM THOA NGUYEN
- Address
- 2000 RINGWOOD AVE, SAN JOSE, CA US
- Phone
- 419-419-4192
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AUTOPULSE? LI-ION BATTERY | LI-ION BATTERY, RECHARGEABLE | ZOLL CIRCULATION | MOQ | MODEL 100 | 8700-0752-01 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-13 | 0 |
Event Narratives#
D
Patient 1
DURING SHIFT CHECK, CUSTOMER REPORTED THAT THE AUTOPULSE LI-ION BATTERY (SERIAL # (B)(4)) DOES NOT POWER ON SEVERAL AUTOPULSE PLATFORMS WHEN INSERTED. NO PATIENT INVOLVEMENT.