MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-02 for RESQPUMP manufactured by .
[137675748]
The force gauge was zeroed when first removed from the box. When the pump was compressed for the first time, it got stuck at (b)(6). After taking the clamshell apart, the spring and gauge were in the correct orientation. The pushrod could be pulled out but it was tough to do so. Part of the pushrod stem was covered with loctite. When the pump was reassembled, the gauge worked normally. The investigation indicates that an excessive amount of loctite was put on the pushrod stem which caused it to get stuck temporarily during compression.
Patient Sequence No: 1, Text Type: N, H10
[137675749]
This resqpump was identified during the daily check of the device and not during patient care. The resqpump's red arrow on the force gauge sticks and does not always return to the "zero" position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2019-00005 |
| MDR Report Key | 8384430 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-02 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2019-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer G1 | ADVANCED CIRCULATORY |
| 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 | 2019-03-02 |
| Returned To Mfg | 2019-03-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-02 |