MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-19 for AUTOPULSE? PLATFORM RESUSCITATION MODEL 100 8700-0740-08 manufactured by Zoll Circulation.
[184994556]
Zoll has not received the autopulse platform for investigation. A follow-up report will be submitted when the product is returned and the investigation has been completed. The patient's death was not related to the autopulse device. Based on available information, the event of "a massive fat embolism in the lungs and multiple injuries" were possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out. Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events. Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs. The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr. Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage. Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr. The 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth. Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr. Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr. The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death. 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. The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients. " the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr. The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death. " the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest. "
Patient Sequence No: 1, Text Type: N, H10
[184994557]
During patient use, after every shock, the autopulse platform performed 2 to 3 compressions and stopped. The crew pulled up the lifeband each time to restart the compressions and the platform continued to stop after performing 2 to 3 compressions. Unknown if manual cpr was performed. The return of spontaneous circulation (rosc) was not achieved and the patient was pronounced dead. Per forensic autopsy results, the patient was diagnosed with a massive fat embolism in the lungs and multiple injuries. The information on the type and location of the injuries were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00282 |
| MDR Report Key | 9858189 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-19 |
| 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? PLATFORM RESUSCITATION |
| Generic Name | CARDIAC CHEST COMPRESSOR |
| Product Code | DRM |
| Date Received | 2020-03-19 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0740-08 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2020-03-19 |