MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-06 for PHYSIO-CONTROL manufactured by Physio-control Inc..
[94353312]
A (b)(6) male arrived to the ed post cardiac arrest. The pt underwent angiography with stent to lad and diagonal as well as placement of intra-aortic balloon pump. He was started on the hypothermia protocol via the arctic sun. Pt had a 2nd cardiac arrest in the ccu requiring multiple rounds of cpr and 6 shocks to achieve rosc (return of spontaneous circulation). During the first shock an arc was seen across the pt's chest. There was a burn that occurred under the true cpr device. The device was removed during the subsequent 5 shocks and then taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073804 |
| MDR Report Key | 7095685 |
| Date Received | 2017-12-06 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-11-18 |
| Date Added to Maude | 2017-12-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHYSIO-CONTROL |
| Generic Name | TRUE CPR |
| Product Code | LIX |
| Date Received | 2017-12-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-06 |