MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-29 for RESQPUMP manufactured by .
[93703479]
There is damage to the key in the lower clamshell that prevents the stem from turning, that could have occurred when the stem came off and another compression came down, binding up the guide. There is not similar damage on the mating notch in the stem. There is white plastic shavings inside the socket on the suction cup that the stem inserts into. There is also some of the same inside the stem, likely from rubbing on the spring. The original pink loctite is visible at the base of the bevel on the screw head. There is also green thread locker on about the last 3/8" of threads. That's not factory issue, so applied afterwards. The threads aren't stripped out, and there's not much evidence of wear,,, brass shavings or corrosion. The screw threads into the brass spring end easily, there is some play, not excessive. No evidence of tampering or damage was present on the inside of the clamshell.
Patient Sequence No: 1, Text Type: N, H10
[93703480]
During a cardiac arrest, yesterday, (b)(6) 2017 we utilized the resqpump on a female patient. During use (a 20+ minute on scene evolution) the phillips head screw that is vertically installed in the white plunger section backed out and caused the pump to come apart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00009 |
| MDR Report Key | 7069048 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2017-11-29 |
| 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 | MS 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 SYSTEMS |
| Manufacturer Street | 1905 COUNTY ROAD C WEST |
| Manufacturer City | ROSEVILLE MI 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| 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 | 2017-11-29 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-29 |