MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-06-29 for PSI-TEC III INFILTRATOR PT-PINF-III manufactured by Byron Medical, Inc..
[21963502]
The dr. Indicates that the o. R. Nurse went to adjust the setting on the unit, and it gave her a "small electrical jolt". Immediately after, the unit stopped working completely. The switch will not power up the unit or the foot pedal. The dr. Stated that this was not a significant event.
Patient Sequence No: 1, Text Type: D, B5
[21989804]
Initial evaluation of the unit indicated that the device had no power when proper connected. Visual evaluation revealed that the three screws on the back of the device were rusty, indicated that fluid had been in the location for some time. Two of the three screws under the cam and bearing appear to have been removed as they were hitting the bottom of the bearing. This indicates that the top of the unit had been removed at one time. Further electrical evaluation revealed that, the fuse had blown due to water in the motor. Water can only get to this area if the unit had been immersed in liquid. Page 7 of 12 in operations manual indicates to the user in a warning statement not to immerse in liquid, and not to open the case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025576-2006-00004 |
| MDR Report Key | 736919 |
| Report Source | 05,06 |
| Date Received | 2006-06-29 |
| Date of Report | 2006-02-09 |
| Date of Event | 2006-02-09 |
| Date Added to Maude | 2006-07-20 |
| 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 | 0 |
| Manufacturer Contact | STEVEN JACKSON |
| Manufacturer Street | 602 W. RILLITO ST |
| Manufacturer City | TUCSON AZ 85705 |
| Manufacturer Country | US |
| Manufacturer Postal | 85705 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSI-TEC III INFILTRATOR |
| Generic Name | INFILTRATION PUMP |
| Product Code | DQI |
| Date Received | 2006-06-29 |
| Model Number | PT-PINF-III |
| Catalog Number | PT-PINF-III |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 724807 |
| Manufacturer | BYRON MEDICAL, INC. |
| Manufacturer Address | * TUCSON AZ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-29 |