MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-20 for AUTOPULSE? LI-ION BATTERY MODEL 100 8700-0752-01 manufactured by Zoll Circulation.
[182965382]
Zoll has not received the product for investigation. A follow-up report will be submitted when the product is returned and investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[182965383]
During shift check, customer reported that autopulse li-ion batteries were discharging voltage rapidly when inserted into the autopulse platform (serial #(b)(4)). No patient involvement. Autopulse platform was submitted under mdr 3010617000-2020-00029.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00119 |
| MDR Report Key | 9608638 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2019-12-26 |
| Date Added to Maude | 2020-01-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KIM THOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE, |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4084192922 |
| Manufacturer G1 | ZOLL CIRCULATION |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOPULSE? LI-ION BATTERY |
| Generic Name | LI-ION BATTERY, RECHARGEABLE |
| Product Code | MOQ |
| Date Received | 2020-01-20 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0752-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION |
| Manufacturer Address | 2000 RINGWOOD AVE. SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-20 |