MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-20 for TWINS CAPABLE FETAL MONITOR M1350A manufactured by Hewlett Packard Co..
[16538]
Quoted from nurse's report "i have both efm (external fetal monitor) and ifm (internal fetal monitor) recorded fhr (fetal heart rate) 110-120's for #1 twin from 1511 pm until pt brought to delivery room at 2238; there was both audible and visible tracing. I brought fetal monitor to delivery room and continued to use external fetal monitor on both twin 1 and twin 2 during forceps delivery. At delivery of twin 1's head it was obvious that she, an infant girl, was a fetal death in utero probably greater than 48 hours because of the macerated appearance. " twin #2 was delivered alive without incident. An autopsy was performed on twin #1. The autopsy report revealed: 1. Intrauterine fetal demise. 2. Macerated 36 week female fetus (202. 5 grams). 3. Dichodonic; diamniotic placenta showing multiple foci of villous edema consistent with fetal hypoxia. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 31564 |
| MDR Report Key | 31564 |
| Date Received | 1996-03-20 |
| Date of Report | 1996-03-06 |
| Date of Event | 1996-01-22 |
| Date Facility Aware | 1996-01-26 |
| Report Date | 1996-03-06 |
| Date Added to Maude | 1996-04-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TWINS CAPABLE FETAL MONITOR |
| Generic Name | TWINS CAPABLE FETAL MONITOR |
| Product Code | KXN |
| Date Received | 1996-03-20 |
| Model Number | M1350A |
| ID Number | ABA C13312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 32704 |
| Manufacturer | HEWLETT PACKARD CO. |
| Manufacturer Address | 3000 MINUTE MAN RD ANDOVER MA 018101087 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-03-20 |