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 2020-02-28 for PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM FFPH5405 manufactured by Philips Medical Systems, Inc..
[181554535]
Reportedly, post repair, the device was getting hot while on the charger. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007409280-2020-00042 |
| MDR Report Key | 9771197 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4495328128 |
| Manufacturer G1 | AVANTE HEALTH SOLUTIONS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM |
| Generic Name | CORDLESS FETAL TRANSDUCER |
| Product Code | HGM |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-11 |
| Model Number | FFPH5405 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | NEDERLAND B.V. POSTBUS 10.000 DA BEST 5680 NL 5680 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |