MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-05 for RESQPUMP manufactured by .
[110177394]
Upon first inspection, the pump appeared to be in good condition with no obvious signs of tampering or damage. The force gauge could move but would sometimes get stuck temporarily during compression. All of the components inside the clamshell were in the right place. The pushrod could be removed but it was harder to do than average. A significant portion of the stem was covered with an excessive amount of loctite. When the pump was reassembled, the pump would still get stuck temporarily. This indicates that an excessive amount of loctite was used on the pushrod stem which caused it to get stuck temporarily during compression.
Patient Sequence No: 1, Text Type: N, H10
[110177395]
Metronome stopped working, found on shift check. Force gauge sticking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2018-00003 |
| MDR Report Key | 7571479 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-05 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-06-05 |
| 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 WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2018-06-05 |
| Returned To Mfg | 2018-05-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-05 |