MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-02 for RGM ANESTHESIA GAS ANALYZER * manufactured by Datex Ohmeda.
[414431]
Enclosed is a copy of the 5250 respiratory gas monitor operation and maintenance manual, part #6050-004-020; 5250 respiratory gas monitor service manual, part #6050-0004-022; and performance testing results, dated january 9, 1992, for the axc-200 bench. The sample (bench) was returned to the manufacturing site for investigation. The bench was installed in a calibration chamber for testing. The measurement results were within manufacturer's specifications, however, the measurign card alarmed "sampling system error" due to the weak signal from the bench. Signal levels were subsequently checked, and it was found that the signal decreased to approx. 1/3 of the original. The signal decreased to approx. 1/3 of the original. The signal from the measuring side and reference side were equal, which indicates that there is no dirt inside the bench. The infrared source resistance was then checked and found to be within manufacturer's specification. The unit was subsequently tested with a new ir source, providing the same results (decrease in signal). The bench was opened and visually inspected, and no anomalies were noted. The unit was tested with another preamplifier board, and the signal levels were within specification. It appears that a weak ir detector caused the signal drop from the bench. Amplification of the preamplifier card was increased, bringing the signal level to within specification. The exact root cause of the ir detector component failure could not be determined. Ge healthcare's evaluation of the reported complaint determined it was not a reportable event that required a mandatory report by the manfacturer. The unit operated as designed, alarming `gas analyzer inoperative' when the unit detected a problem. There was no reported patient injury (as stated in the user report). Manufacturing of the 5250 respiratory gas monitor ended december 2001.
Patient Sequence No: 1, Text Type: D, B5
[436248]
An anesthesia gas monitor being used in the operating room failed shortly after the patient's induction. It displayed the message, gas analyzer inoperative. The monitor was then switched out for a same model replacement. The operation continued without further incidents regarding the monitor. It was taken to the biomedical engineering department for troubleshooting. During the exam, another indicator displayed was a?? Agent detecteda?? Even though there was no agent being introduced. It is being sent out to the manufacturer for repair. The patient was not injured by this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 631888 |
| MDR Report Key | 631888 |
| Date Received | 2005-08-02 |
| Date of Report | 2005-08-02 |
| Date of Event | 2005-07-08 |
| Report Date | 2005-08-02 |
| Date Reported to FDA | 2005-08-02 |
| Date Added to Maude | 2005-08-31 |
| 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 | 3 |
| 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 | RGM ANESTHESIA GAS ANALYZER |
| Generic Name | ANESTHETIC GAS MONITOR |
| Product Code | CCL |
| Date Received | 2005-08-02 |
| Model Number | RGM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 8 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 621470 |
| Manufacturer | DATEX OHMEDA |
| Manufacturer Address | PO BOX 7550 MADISON WI 53707 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-02 |