MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-17 for RESQPUMP manufactured by .
[90417914]
The pump arrived with no apparent evidence of modification or misuse of the device. Brass shavings were evident inside the connector stem and along the m5 screw threads. The connector stem had some scratches at the bottom where it connects to the lower clamshell. There was also some wear on the face of the anchor lower nut. This wear is not normally observed in used devices and presumably occurred during separation. The washer was bent considerably but it is unknown when this occurred. When the stem was reassembled with the bent washer the stem wasn't able to be fully seated. This resulted in that assembly being very loose which would results in a fair amount of unintended movement in the system during use. There was some wear at the end of the m5 screw indicating that, at least at one time, the screw was fully engaged. Information on calibration/maintenance events on this device is unknown there is little evidence if any of calibration as the adjustment screw is in good condition. 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
[90417915]
During patient use on (b)(6), the plunger separated from the handle. The customer reverted to manual cpr until a replacement arrived on scene. Patient was a (b)(6) year old female. No adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00007 |
| MDR Report Key | 6955343 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-09-02 |
| Date Mfgr Received | 2017-09-18 |
| Date Added to Maude | 2017-10-17 |
| 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 |
| 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 | 2017-10-17 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |