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 PHILIPS M1019A G5 ANESTHETIC GAS ANALYZER FGPH1019 manufactured by Draeger Medical, Inc..
[177837280]
The complaint device was returned for evaluation. Incoming visual inspection found that the warranty label was compromised. Device evaluation is identified that the dir sensor was causing bad co2 readings confirming the reported event. The dir sensor was replaced and the device was calibrated testing to oem specifications. The case was also checked for damage. The root cause for the reported event is determined to be the aged dir sensor. 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
[177837281]
Reportedly, post repair, the co2 keeps climbing when connected to a patient. There was no report of patient harm. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007409280-2020-00030 |
| MDR Report Key | 9667355 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-04 |
| Date of Report | 2018-12-26 |
| Date Mfgr Received | 2018-12-26 |
| 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 | PHILIPS M1019A G5 ANESTHETIC GAS ANALYZER |
| Generic Name | ANESTHETIC GAS MONITOR |
| Product Code | CCK |
| Date Received | 2020-02-04 |
| Returned To Mfg | 2019-01-08 |
| Model Number | FGPH1019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL, INC. |
| Manufacturer Address | 3135 QUARRY RD. TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |