MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-30 for RESQPUMP manufactured by .
[93475390]
The pump arrived with no apparent evidence of modification or misuse of the device. Steele shavings were evident inside the connector stem and under the m5 screw head. There is damage to the key in the lower clamshell that prevents the stem from turning. This probably occurred when the stem became partially disengaged (enduser stated the stem seemed to get dislodged before full separation) and another compression came down. There is no damage on the mating notch in the stem. Information on calibration/maintenance events on this device is unknown. There is evidence of calibration as there was loctite at the bottom of the screw which is not applied there during manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[93475391]
During compression resqpump separated into two parts: handle, pump. Manual cpr continued and a second device was used to continue itd therapy. No effect on outcome of patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00008 |
| MDR Report Key | 7071239 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-30 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2017-10-31 |
| Date Added to Maude | 2017-11-30 |
| 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 WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035600 |
| Manufacturer G1 | ADVANCED CIRCULATORY SYSTEMS |
| Manufacturer Street | 1905 COUNTY ROAD C WEST |
| 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 |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2017-11-30 |
| Returned To Mfg | 2017-11-08 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-30 |