MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-20 for RESQPUMP 12-0823-000 manufactured by Advanced Circulatory.
[73341847]
The pump arrived partially assembled. The m5 washer wasn't included in the return however there is evidence that there had been a washer installed previously. When or how the washer was separated from the system is unknown. The on -scene supervisor reported that the pump had been in use for over 30 minutes before the failure occurred. It is evident that the m5 screw was engaged in the threads (fully seated or not is unknown) and backed out during operation. Brass shavings were in the screw threads along the entire engagement depth indicating that, at least at one time, the screw was fully engaged. The threads were fairly loose but not completely stripped. The clamshell/stem key feature, which aligns the two, showed signs of damage at the top. Information on calibration/maintenance events on this device has been requested as the screw in question is removed during calibration. The ifu provides the re-calibration instructions for the user to re-zero the force gauge. This includes removing the suction cup, loosening the screw and reassembling the device. There is evidence of calibration as the adjustment screw head is partially stripped. The user has not confirmed any maintenance performed. In summary, the problem with the device was the unintentional separation of the stem/suction cup assembly from the rest of the device due to a problem during operational performance. Without being able to re-create the failure and/or further information we are unable to confirm the complaint.
Patient Sequence No: 1, Text Type: N, H10
[73341848]
While using the resqpump to perform cpr on a patient on the floor of a residence, the rescue pump malfunctioned and separated into two pieces. The soft plastic plunger separated from the hard plastic base during the upward portion of the normal compression cycle. The pump was positioned appropriately on the chest and seemed to be working fine through several cycles of use and through multiple users until it started to get loose and finally separate. We were able to continue cpr and retrieve another device to continue the resuscitation effort. A quick examination of the device on scene showed that a main center screw in the device had backed out to the point of device failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00001 |
| MDR Report Key | 6510141 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2017-02-27 |
| Date Added to Maude | 2017-04-20 |
| 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 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 54025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54025 |
| 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 | 2017-04-20 |
| Returned To Mfg | 2017-03-20 |
| 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 |
| Manufacturer Address | 1905 COUNTY RD C WEST ROSEVILLE MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |