MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-14 for NAVIGATOR GPS NAVIGATOR/GPS N/A manufactured by Rmd Instruments Corporation.
[1153549]
We were using the navigator when, suddenly, it would not read the numbers and caused a delay in our procedure. We had to retrieve another gps navigator from an ent room. The cord had been broken at the plug where it plugs into the machine and then taped with the pink anesthesia tape instead of being sent to biomed. We had to hold the cord in place in order for the gps navigator to work. We have had numerous problems with these cords.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1462594 |
| MDR Report Key | 1462594 |
| Date Received | 2009-08-14 |
| Date of Report | 2009-08-12 |
| Date of Event | 2009-07-02 |
| Report Date | 2009-08-12 |
| Date Reported to FDA | 2009-08-14 |
| Date Added to Maude | 2009-09-04 |
| 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 |
| 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 | NAVIGATOR GPS |
| Generic Name | GAMMA COUNTER |
| Product Code | IZD |
| Date Received | 2009-08-14 |
| Model Number | NAVIGATOR/GPS |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RMD INSTRUMENTS CORPORATION |
| Manufacturer Address | 44 HUNT STREET WATERTOWN MA 02472 US 02472 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-14 |