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 2020-01-22 for PHILIPS AVALON FM20 FETAL MONITOR FQPH8820 manufactured by Philips Medical Systems, Inc..
[177826501]
The complaint device was returned for evaluation. Incoming visual inspection identified that the warranty label had been compromised. Device evaluation identified that the fetal sensor compartment was open, the unit was missing the interfaces card, and the touch screen panel did not work. The touch screen assembly was replaced. The fetal sensor compartment was re-installed. The software was reloaded. The pcb (c73) was refurbished. The device was tested on a simulator. The root cause is most likely due to the device being opened by the customer; however, this cannot be confirmed. This type of reported 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
[177826502]
Reportedly, post repair, the fetal heart tones were showing to be in the 230's. It was noted that it was clear that the heart tones were not that high based on hearing them. The customer stated they had tried several different transducers with the same result. There was no report of patient harm. No additional event or patient information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007409280-2020-00012 |
| MDR Report Key | 9618325 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-01-22 |
| Date of Report | 2018-07-25 |
| Date Mfgr Received | 2018-07-25 |
| Date Added to Maude | 2020-01-22 |
| 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 AVALON FM20 FETAL MONITOR |
| Generic Name | PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 |
| Product Code | HGM |
| Date Received | 2020-01-22 |
| Returned To Mfg | 2018-08-15 |
| Model Number | FQPH8820 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 018101099 US 018101099 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |