MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-18 for 12-0823-000 manufactured by .
[108738495]
Upon first inspection, the force gauge was not functional and would instead move when the pump was rotated from side to side. After opening the clamshell, the spring (curve cylinder spring: (b)(4) was in place but on the wrong side of clamshell. Because of this, it is likely that the customer opened up the clamshell and reassembled the components incorrectly. When the spring was put in properly, the force gauge worked correctly. The incorrectly inserted spring is what caused the issues with the force gauge and it was due to the customer reassembling the components of the clamshell incorrectly, not a problem with the design or manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[108738497]
Resqpump found on shift check dead battery. Force gauge stuck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2018-00002 |
| MDR Report Key | 7526261 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-18 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-05-18 |
| 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 | MS 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 | 2018-05-18 |
| Returned To Mfg | 2018-04-25 |
| Model Number | 12-0823-000 |
| 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 | 2018-05-18 |