MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-08 for RESQCPR SYSTEM 12-0823-000 manufactured by .
[27809226]
Preliminary findings indicate that the hole in the clam shell lower handle is undersized and out of specification. Therefore when the transfer spring subassembly is secured into the clamshell lower assembly, a potential exists for an interference fit to occur between these parts. Due to this interference fit, when the resqpump is exercised during cpr the transfer spring will wear or distort the hole in the lower clamshell handle, reducing the friction fit between the transfer spring subassembly and lower clamshell. The result of this wear or distortion is that the unit allows the transfer spring subassembly to translate up and down in the socket in the clamshell, coinciding with compressions and decompressions and may develop a "clicking" sound. This motion of the transfer spring subassembly may affect the calibration of the force gauge on the device as the two components progressively wear together.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2015-00003 |
| MDR Report Key | 5134648 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-08 |
| Date of Report | 2015-10-01 |
| Date of Event | 2015-08-31 |
| Date Added to Maude | 2015-10-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE HOWELL |
| Manufacturer Street | 1905 COUNTY ROAD C |
| 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 | RESQCPR SYSTEM |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2015-10-08 |
| Returned To Mfg | 2015-09-18 |
| Catalog Number | 12-0823-000 |
| Lot Number | 44598758 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |