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 2020-02-27 for AUTOPULSE? LI-ION BATTERY MODEL 100 8700-0752-01 manufactured by Zoll Circulation.
[186091596]
The li-ion battery in complaint will not be returned for investigation. Therefore, a physical investigation will not be performed. A supplemental report will be filed if the product is returned and investigation has been completed. The death was not related to the autopulse device. The autopulse is used as an adjunct to manual cpr in cases of clinical death. The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions. If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care. The autopulse was intended to be used as an adjunct to manual cpr on adult patients. In case of stoppage of autopulse the trained user reverts to manual cpr. The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr. Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr. Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations. About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015). In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10. 6% for patients of any age. Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31. 4% of victims survived to hospital discharge (mozaffarian, circulation, 2016). Death is an expected outcome for ohca.
Patient Sequence No: 1, Text Type: N, H10
[186091597]
The autopulse platform (sn: unknown) was used on a (b)(6) male patient who had a relatively short downtime with a shockable cardiac rhythm. The autopulse platform stopped after few compressions and displayed user advisory (ua) 17 (max motor on time exceeded during active operation). The use of the platform was discontinued, and manual cpr was performed during troubleshooting. The ems crew decided to use the second autopulse platform (sn: unknown), which was on the scene. However, the second platform also stopped after few compressions and displayed ua17. Lifebands were switched, but the issue was not resolved. Use of the second platform was also discontinued, and manual cpr was performed for 45-50 minutes. However, return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead. As per customer, it is unknown if the patient's death was related to the reported issues on the autopulse systems. As per customer, two autopulse li-ion batteries with serial numbers sn: (b)(4) and sn: (b)(4)were used in this reported event. Both batteries were fully charged prior to inserting into the autopulse platforms. Both batteries were last fully charged on (b)(6) 2020, two days prior to the reported event date. After the incident, the batteries were attempted to be charged in an autopulse multi-chemistry charger (mcc), and both batteries displayed green flashing led lights. Please see the following related mfr report: mfr # 3010617000-2020-00270 for the autopulse platform (sn: unknown). Mfr # 3010617000-2020-00271 for the autopulse platform (sn: unknown). Mfr # 3010617000-2020-00233 for the 1st autopulse li-ion battery (sn: (b)(4))
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00203 |
| MDR Report Key | 9766834 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2015-05-18 |
| Date Added to Maude | 2020-02-27 |
| 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 | 2020-02-27 |
| Returned To Mfg | 2020-03-04 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0752-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-27 |