MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-17 for 12-0823-000 manufactured by .
[108615237]
Upon first inspection, the d-ring (b)(4) was disconnected from the upper clamshell which could have happened when the customer opened the clamshell. The force gauge was non-functional as reported and would instead move when the pump was rotated from side to side. The spring (curve cylinder spring: (b)(4) was backwards which is what caused the force gauge not to work. When the spring was put in properly, the force gauge worked correctly. Because of these three issues (d-ring, spring, and pcb out of place), it is likely that the customer opened up the clamshell and reassembled the components incorrectly. The incorrectly inserted spring caused the issue with the with the force gauge not working. This problem because was due to the customer reassembling the clamshell components incorrectly, not a problem with the design or manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[108615238]
Resqpump found on shift check dead battery and force gauge stuck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2018-00001 |
| MDR Report Key | 7524200 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-17 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2018-04-19 |
| Date Added to Maude | 2018-05-17 |
| 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 | 6514035600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2018-05-17 |
| 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 | 2018-05-17 |