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 2020-03-03 for AUTOPULSE? LI-ION BATTERY MODEL 100 8700-0752-01 manufactured by Zoll Circulation.
[186565866]
The device associated with this complaint was discarded by the customer. Since the device was not returned, an investigation could not be performed and a root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[186565867]
During shift check, the autopulse platform displayed "replace battery" message upon insertion of the fully charged autopulse li-ion battery (sn: (b)(4)). The battery was placed into the autopulse multi-chemistry battery charger (mcc) for more than 24 hours; however, the status led on the charger showed amber light (test-cycle). There was no device malfunction reported on the autopulse platform, and the platform functioned as intended with different batteries. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00209 |
| MDR Report Key | 9781699 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2017-03-29 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4192922 |
| Manufacturer G1 | ZOLL CIRCULATION |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| 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 | 2020-03-03 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0752-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |