MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for RESQPUMP 12-0823-000 manufactured by Advanced Circulatory.
[40208403]
A (b)(6) female, cardiac arrest, possible pneumothorax.
Patient Sequence No: 1, Text Type: N, H10
[40208404]
A (b)(6) female, cardiac arrest, possible pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000143502-2016-00002 |
| MDR Report Key | 5496414 |
| Date Received | 2016-03-11 |
| Date of Report | 2016-03-11 |
| Date of Event | 2015-12-10 |
| Date Mfgr Received | 2016-02-25 |
| Date Added to Maude | 2016-03-11 |
| 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 | MS 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 | ST. LOUIS PARK MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESQPUMP |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2016-03-11 |
| 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 |
| Manufacturer Address | 1905 COUNTY ROAD C ROSEVILLE MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-11 |