MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-13 for INTELLIGENT INFUSOR 2001 UNK manufactured by Mcgaw Medical.
[37611]
Ob pt was started on pitocin controlled by iv controller set at 3ml/hr. Three minutes later rn noted fhr deceleration. Rn placed controller on hold. After two add'l minutes rn noted apparent free flow and clamped tubing. Unknown amount of medication delivered. Treated pt with 02, position change and iv flush for uterine tetany and fhr deceleration. Delivered by c section 2-1/2 hrs later. No known adverse effect on mother or baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 57101 |
| MDR Report Key | 57101 |
| Date Received | 1996-12-13 |
| Date of Report | 1996-06-20 |
| Date of Event | 1996-06-07 |
| Date Facility Aware | 1996-06-07 |
| Report Date | 1996-06-20 |
| Date Reported to Mfgr | 1996-06-20 |
| Date Added to Maude | 1996-12-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | INTELLIGENT INFUSOR |
| Generic Name | INFUSION CONTROLLER |
| Product Code | LDR |
| Date Received | 1996-12-13 |
| Model Number | 2001 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 57602 |
| Manufacturer | MCGAW MEDICAL |
| Manufacturer Address | 1601 WALLACE DR CARROLLTON TX 75006 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-13 |