MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-29 for RESQPUMP 12-0823-000 manufactured by Advanced Circulatory.
[78774989]
The pump came to acsi with the force gauge reading at 0 kg. The gauge worked as expected for a few compressions then stuck at 30 kg momentarily, then released and returned to 0. Nothing external or internal indicated that there were any modifications or misuse of the device. The pushrod assembly was not stuck in the transfer spring, however when removing it was somewhat rough, especially the last third of the pushrod. The pushrod loosened up after some manipulation. The components were reassembled and the force gauge returned to zero. The force gauge worked smoothly and did not get hung up again after several compressions. The force gauge was verified on a scale (force gauge kg/scale kg; -15/-14, 50/48) all within specification. The gauge returned to zero after each compression/decompression. It is thought that excess loctite was on the pushrod stem. When the pump was compressed the pushrod must have gotten stuck in the up position causing the gauge to read high and not return to zero for a time.
Patient Sequence No: 1, Text Type: N, H10
[78774990]
Out of box failure. No patient involvement. Force gauge not in calibration and stuck in compression mode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00003 |
| MDR Report Key | 6678700 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-06-29 |
| 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 D |
| Manufacturer Street | 1905 COUNTY RD C WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035600 |
| Manufacturer G1 | SCIENTIFIC MOLDING CORPORATION |
| Manufacturer Street | 330 SMC DRIVE |
| Manufacturer City | SOMERSET WI 55425 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55425 |
| 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 | 2017-06-29 |
| Returned To Mfg | 2017-05-27 |
| Model Number | 12-0823-000 |
| Lot Number | 51733641 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED CIRCULATORY |
| Manufacturer Address | 1905 COUNTY RD C WEST ROSEVILLE MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-29 |