MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-22 for 12-0823-000 manufactured by .
[95948941]
When the metronome button was pushed, no sound was generated. After taking the clamshell apart, the pcb and flex-circuit were inspected for irregularities. Some corrosion was identified on the flex-circuit along with some particulate on the inside of the clamshell. No gross errors were detected on the pcb (missing components, broken solder joints) but corrosion was identified at one of the battery terminals along with potential damage to the battery itself. When a different pcb and battery were used, the metronome worked. Resqpumps getting stuck in the compressed position is being investigated under capa (b)(4)-main. Because this investigation is still ongoing, fer (b)(4) was also inspected for this issue. When the pump was compressed, the force gauge was stuck at 50 kg. When the clamshell was taken apart, all components seemed to be in the correct orientation. The pushrod could be removed but it was harder to do so than average. A significant portion of the pushrod stem was covered with an excessive amount of loctite. When the pump was reassembled, the pump would still stick at 50 kg after the first compression. The investigation indicates that moisture was introduced to the inside of the clamshell causing corrosion and subsequent battery depletion. It also indicates that an excessive amount of loctite was put on the pushrod stem which cause it to get stuck at the point of maximum compression.
Patient Sequence No: 1, Text Type: N, H10
[95948942]
Originally reported as a metronome stopped working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00010 |
| MDR Report Key | 7144242 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-22 |
| Date of Report | 2017-12-22 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2017-11-15 |
| Date Added to Maude | 2017-12-22 |
| 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 | 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 | ADVANCED CIRCULATORY SYSTEMS |
| Manufacturer Street | 1905 COUNTY ROAD C WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2017-12-22 |
| Returned To Mfg | 2017-11-28 |
| Model Number | 12-0823-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-22 |