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 2020-02-07 for PHILIPS M1026B ANESTHETIC GAS MODULE FGPH1026B manufactured by Philips Medizin Systeme Boeblingen Gmbh.
[178965787]
The complaint device was returned for evaluation. Device sent in due to the device shutting down in the middle of a procedure. Incoming visual inspection found no anomalies. Device evaluation found no problem. The device was calibrated, the case and front/rear connectors were inspected. The circuit boards were inspected. The reported event was unable to be duplicated and there was no problem found; therefore, a root cause cannot be determined. 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
[178965788]
Reportedly, post repair, the device failed during a procedure as it shut off. There was no report of patient harm or intervention. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007409280-2020-00040 |
| MDR Report Key | 9684663 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2018-07-23 |
| Date Mfgr Received | 2018-07-23 |
| Date Added to Maude | 2020-02-07 |
| 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 M1026B ANESTHETIC GAS MODULE |
| Generic Name | ANESTHETIC GAS MODULE |
| Product Code | CBQ |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2018-08-01 |
| Model Number | FGPH1026B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
| Manufacturer Address | HEWLETT-PACKARD-STR.-2 BOEBLINGEN, 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |