MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-30 for RESQPUMP 12-0823-000 manufactured by Advanced Circulatory Systems.
[118893114]
The pump arrived with evidence it had been opened. The strap had been removed which cannot occur without the clamshell being separated. The force gauge pointer was at 30 kg however was upside down indicating it was reassembled incorrectly, however this is not possible due to the clamshell's design. Upon opening the clamshell it was clear that the pointer was not upside down but the top clamshell had been reassembled upside down. The gauge seemed to be working properly but with the clamshell being upside down it appeared to be reading between 30 and 40. The white connector stem not tightly secured to the clamshell handle as a result of the m5 screw not fully engaged. Given that the pump had clearly been tampered with, we are unable to confirm whether the device truly had a stuck force gauge as the customer described or just appeared to due to the incorrect reassembly.
Patient Sequence No: 1, Text Type: N, H10
[118893115]
The red arrow on the force gauge is staying between the 30kg and 40kg range and not returning back to the neutral position. Captain sauder placed the resqpump on the table and pumped up and down. The red arrow did return to the neutral position, but within a few seconds fell back down to the between the 30kg and 40kg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2018-00004 |
| MDR Report Key | 7832871 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-08-30 |
| 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 RD 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 |
| Brand Name | RESQPUMP |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2018-08-30 |
| Returned To Mfg | 2018-08-24 |
| Model Number | 12-0823-000 |
| Lot Number | 50908708 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED CIRCULATORY SYSTEMS |
| Manufacturer Address | 1905 COUNTY RD C WEST ROSEVILLE MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-30 |