MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-04 for GE SAM GAS ANALYZER FGGE3000 manufactured by Marquette Electronics, Inc..
[177837117]
The complaint device was returned for evaluation. Incoming visual inspection found no anomalies. Device evaluation is identified that the unit was overheating due to dust build-up around the fan and the readings were out of tolerance confirming the reported event. The dust build-up was removed. The device was calibrated. The front and rear connectors, and housing was checked for damage. The root cause for the reported event is determined to be a result of normal use. This type of event will continue to be monitored. It should be noted that this is being filed based on retrospective review.
Patient Sequence No: 1, Text Type: N, H10
[177837118]
Reportedly, post repair, the readings were incorrect. There was no report of patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007409280-2020-00029 |
| MDR Report Key | 9665815 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-04 |
| Date of Report | 2019-02-04 |
| Date Mfgr Received | 2019-02-04 |
| Date Added to Maude | 2020-02-04 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNA VARGAS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal | 92672 |
| Manufacturer Phone | 8004495328 |
| Manufacturer G1 | AVANTE HEALTH SOLUTIONS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE SAM GAS ANALYZER |
| Generic Name | SMART ANESTHESIA MULTI-GAS (SAM) MODULE |
| Product Code | CCK |
| Date Received | 2020-02-04 |
| Returned To Mfg | 2019-02-07 |
| Model Number | FGGE3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARQUETTE ELECTRONICS, INC. |
| Manufacturer Address | 8200 WEST TOWER AVE. MILWAUKEE WI 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |