MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-11 for RESQPUMP manufactured by .
[123494681]
The resqpump arrived with the suction cup/connecter stem assembly separated from the handle/spring assembly. The m5 washer was not included in the return however there is evidence that there had been a washer installed previously. When or how the washer was separated from the system is unknown. There was a good amount of white plastic shavings on the lower spring nut and inside the suction cup's connection stem recess. The clamshell/stem key feature, which aligns the two, showed signs of damage at the top. The damage is presumably due to friction while the m5 screw was in the process of backing out. It is evident that the m5 screw was engaged in the threads (fully seated or not is unknown) and backed out during operation. Brass shavings were in the screw threads along the entire engagement depth indicating that, at least at one time, the screw was fully engaged.
Patient Sequence No: 1, Text Type: N, H10
[123494682]
The resqpump came apart during a resuscitation effort. As far as the impact is unknown, manual compressions were started and continued from that point forward. I was not on scene but as far as i can tell, the pt was being moved down a flight of stairs and cpr being performed during this process. Once at bottom of stairs the device came apart leaving half on pt chest and other half in emt's hand. It seems that the nut that holds the two together came apart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2018-00005 |
| MDR Report Key | 7958524 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-09-18 |
| Date Added to Maude | 2018-10-11 |
| 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 | MRS DIANE HOWELL |
| Manufacturer Street | 1905 COUNTY ROAD C WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESQPUMP |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2018-10-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-11 |