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 2020-02-13 for AUTOPULSE? LI-ION BATTERY MODEL 100 8700-0752-01 manufactured by Zoll Circulation.
[183427740]
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
[183427741]
During patient use, when the autopulse li-ion battery (sn: (b)(4)) was inserted into the autopulse platform, the platform did not power up. The battery was placed back into autopulse multi chemistry charger (mcc). However, the battery failed to charge in the charger, and the mcc status indicator illuminated fail (red led) light. The battery was tested in both bays in the mcc, and the same result was observed. The charger was unplugged for a few minutes and plugged back in, and the battery was tried in both bays again; however, the issue was not resolved. As per customer, the battery was charged prior to inserting into the platform, but the customer couldn't recall what lights were illuminated on the battery status leds. Other batteries were charging fine in the charger. The autopulse platform worked fine with spare battery. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00162 |
| MDR Report Key | 9707456 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-06-05 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| 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 | 2020-02-13 |