MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-18 for RESQCPR SYSTEM 12-0823-000 manufactured by Advanced Circulatory.
[38479368]
An (b)(6) patient in a nursing home was being fed by staff. They turned away and some time later found her in cardiac arrest with asystole. Cpr was started by the nursing home staff. Ems then arrived and used resqcpr including the resqpump. A wound/injury on the patient's chest (skin tear) was observed after that. This was covered with a clear plastic bandage. It is uncertain whether the injury was attributable to the use of the resqpump. Ems personnel continued with manual cpr and the resqpod and she was transported without a pulse and in asystole with ongoing cpr to baptist emergency department where she was declared dead. Death was not attributed to the use of the resqpump or the observed damage to the chest. Ems reported compressions were performed at a depth of 2. 5 inches during use of resqpump which is greater than described in the instructions for use of 1. 5 to 2. 0 inches or 33 to 45 kg.
Patient Sequence No: 1, Text Type: N, H10
[38479369]
An (b)(6) patient in a nursing home was being fed by staff. They turned away and some time later found her in cardiac arrest with asystole. Cpr was started by the nursing home staff. Ems then arrived and used resqcpr including the resqpump. A wound/injury on the patient's chest (skin tear) was observed after that. This was covered with a clear plastic bandage. It is uncertain whether the injury was attributable to the use of the resqpump. Ems personnel continued with manual cpr and the resqpod and she was transported without a pulse and in asystole with ongoing cpr to baptist emergency department where she was declared dead. Death was not attributed to the use of the resqpump or the observed damage to the chest. Ems reported compressions were performed at a depth of 2. 5 inches during use of resqpump which is greater than described in the instructions for use of 1. 5 to 2. 0 inches or 33 to 45 kg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000143502-2016-00001 |
| MDR Report Key | 5444840 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-18 |
| Date of Report | 2016-01-21 |
| Date of Event | 2016-01-16 |
| Date Mfgr Received | 2016-01-16 |
| Date Added to Maude | 2016-02-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE HOWELL |
| Manufacturer Street | 1905 COUNTY ROAD C |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035600 |
| Manufacturer G1 | ADVANCED CIRCULATORY |
| Manufacturer Street | 1905 COUNTY ROAD C |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESQCPR SYSTEM |
| Generic Name | RESQCPR SYSTEM |
| Product Code | PIZ |
| Date Received | 2016-02-18 |
| Model Number | 12-0823-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED CIRCULATORY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-18 |