MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-10 for ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON M2736A 862199 manufactured by Philips Medical Systems.
[174656258]
A follow up report will be submitted once the investigation is complete. Date of incident has been requested not available at time of report.
Patient Sequence No: 1, Text Type: N, H10
[174656259]
The customer reported that the report outlines that a fetal heart recording of 192 beats per minute (bpm) was provided by the fetal monitor fm30 and a decision was made to perform a caesarean section. However, upon auscultation it was found to be 80 bpm. A decision was made to perform a caesarean section. It is unknown, if there was any harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2020-00015 |
| MDR Report Key | 9575291 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-10-02 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2013-03-14 |
| Date Added to Maude | 2020-01-10 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | HEWLETT-PACKARD STR.2 |
| Manufacturer City | BOEBLINGEN 71034 |
| Manufacturer Country | GM |
| Manufacturer Postal | 71034 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON |
| Generic Name | ULTRASOUND TRANSDUCER |
| Product Code | HGM |
| Date Received | 2020-01-10 |
| Model Number | M2736A |
| Catalog Number | 862199 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-10 |