MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-22 for UROMAT 3000 S 0116 0024 manufactured by Pausch Llc.
[1524199]
Customer reported the foot switch was inoperable. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8569953]
Eval summary: a foot switch error f31 occurring and all table motions were disabled. The table reset does not clear error because, the malfunctioning footswitch is still attached to the system and the system will still see that it is still in error. A new footswitch was sent out and the system worked as intended. The system performed as designed, because, it did not work in the violative state where the system had detected a malfunction that could affect safety. The violative state being a foot switch error f31 occurring. If a foot pedal switch (or any other switch that control movements) is not working, the system is to disable table motions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243057-2010-00001 |
| MDR Report Key | 1667723 |
| Report Source | 05 |
| Date Received | 2010-04-22 |
| Date of Report | 2010-04-21 |
| Date of Event | 2010-03-23 |
| Date Mfgr Received | 2010-03-23 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2011-01-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 808 SHREWSBURY AVENUE |
| Manufacturer City | TINTON FALLS NJ 077243002 |
| Manufacturer Country | US |
| Manufacturer Postal | 077243002 |
| Manufacturer Phone | 7327476110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROMAT 3000 |
| Generic Name | TABLE, CYSTOMETRIC, ELECTRIC |
| Product Code | MMZ |
| Date Received | 2010-04-22 |
| Model Number | S 0116 0024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PAUSCH LLC |
| Manufacturer Address | TINTON FALLS NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-22 |