MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-06 for LATITUDE * GIM600D00 manufactured by Clinical Innovations, Llc.
[17887932]
Probe was calibrated and channels tested to make sure they worked. When probe was placed in the patient channel five lost its calibration. A resting study was done to see if pressure would come back, but it never did. All of the connections were checked to make sure they were intact. The slider pieces were checked to make sure they were charged. The probe was pulled out and a new probe was calibrated and inserted. The study was completed with a new probe. Company called & rma# was given to send catheter back. Catheter was calibrated and resting pressures gotten. When moving on to squeezes, channel two lost its calibration. All the connections were checked to make sure that they were intact. The sliders pieces were checked to make sure they were still charged. The probe was pulled out and a new probe was calibrated and inserted. Study was completed with new probe. The company was called and rma# given to send catheter back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1590472 |
| MDR Report Key | 1590472 |
| Date Received | 2010-01-06 |
| Date of Report | 2010-01-06 |
| Date of Event | 2009-12-17 |
| Report Date | 2010-01-06 |
| Date Reported to FDA | 2010-01-06 |
| Date Added to Maude | 2010-01-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATITUDE |
| Generic Name | CATHETER, ANAL RECTAL MANOMATORY |
| Product Code | GBT |
| Date Received | 2010-01-06 |
| Returned To Mfg | 2009-12-18 |
| Model Number | * |
| Catalog Number | GIM600D00 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-06 |