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 2020-03-04 for AUTOPULSE? LI-ION BATTERY MODEL 100 8700-0752-01 manufactured by Zoll Circulation.
[186586554]
The reported complaint of "the autopulse platform did not recognize the fully charged autopulse li-ion battery (sn (b)(4))" was not confirmed during the functional testing and based on the archive data review. No device malfunction was observed during the testing and the battery worked as intended. Upon visual inspection, no physical damage was observed and the status led on the battery showed four green lights. The autopulse li-ion battery passed charging in a known good autopulse multi-chemistry battery charger (mcc) and the status led on the battery showed four green lights. The battery was also tested in a known good autopulse platform and the platform performed compressions using large resuscitation test fixture (lrtf) for about 40 minutes and passed the run-in test without any fault or error. The archive data review showed no proof of the battery being used or inserted in the autopulse platform on or around the reported event date, which is (b)(6) 2020. The battery was last charged successfully on (b)(6) 2020 and was last used in the autopulse platform on the same day for about few seconds. However, the archive data showed that the customer inserted the battery in the mcc for charging on (b)(6) 2020 and the battery was not reconditioned and fully charged. The customer pulled out the battery during the conditioning cycle or before it finishes the charging and as a result, the battery recorded charging cancellation event. This could be the probable cause for the customer reported complaint. The autopulse power system user guide states: do not remove a battery from the battery charger until its charging completes, or the battery's run time will be reduced. Do not remove a battery from the battery charger during a test-cycle, or the battery's run time may be reduced. If a battery is removed during a test-cycle, the battery charger will automatically restart the test-cycle the next time the battery is inserted into it. Educated the customer by sending a letter with investigation findings and by providing a copy of the autopulse power system user guide.
Patient Sequence No: 1, Text Type: N, H10
[186586555]
During shift check, the autopulse platform did not recognize the autopulse li-ion battery (sn (b)(4)) charge status. Per user, the battery was fully charged prior inserting into the platform and the battery status led's showed four green lights. The autopulse platform was tested using other autopulse li-ion batteries and the platform worked as intended. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00221 |
| MDR Report Key | 9786581 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-02-20 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| Returned To Mfg | 2020-02-26 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0752-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-04 |