MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-11-02 for ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON M2736A 989803143691 manufactured by Philips Medical Systems.
[125924684]
A follow-up report will be submitted upon completion of the investigation. The device was in use on a patient at the time of the reported event. No further details regarding the baby had been made available at the time of the reporting decision. Philips is in the process of obtaining additional information regarding the reported event. .
Patient Sequence No: 1, Text Type: N, H10
[125924685]
It was reported that there was a "wrong ecg trace issue. The users reported that the ultrasound transducer didn't give the right ecg trace, the ecg trace was shown for a healthy baby's heartbeat, but the baby was born dead".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2018-00303 |
| MDR Report Key | 8032345 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-02 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-12 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2018-11-02 |
| 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 | MR. ROBERT CORNING |
| 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 | 2018-11-02 |
| Model Number | M2736A |
| Catalog Number | 989803143691 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Death | 2018-11-02 |