MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2012-11-16 for FETAL MONITOR SERIES 50 IP M1353A manufactured by Philips Medical Systems.
[21671011]
The customer reported that on (b)(6) 2004, a (b)(6) was born with disabilities while being monitored with a philips fetal monitor. The customer stated that the heart frequency shown on the ctg was incorrectly showing information, where an acoustic heart rate was higher than the recorded heart rate.
Patient Sequence No: 1, Text Type: D, B5
[21887755]
(b)(4). The customer reported that on (b)(6) 2004, a (b)(6) was born with disabilities while being monitored with a philips fetal monitor. The customer stated that the heart frequency shown on the ctg was incorrectly showing information, where an acoustic heart rate was higher than the recorded heart rate. As this issue is under investigation and further details have been requested, it is not possible to evaluate the health risk at this time. Due to one neonate being born with disabilities we are reporting this incident. Philips is in the process of obtaining additional information regarding this incident and the complaint is still under investigation. A final report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610816-2012-00474 |
| MDR Report Key | 2849088 |
| Report Source | 01,05,06,07 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-11-13 |
| Date of Event | 2004-01-31 |
| Date Mfgr Received | 2012-11-13 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 2012-11-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAL MONITOR SERIES 50 IP |
| Product Code | HFM |
| Date Received | 2012-11-16 |
| Model Number | M1353A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-16 |