MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-17 for HUAM UTERINE ACTIVITY MONITOR manufactured by Coram Healthcare Corp..
[18295]
Monitor will not charge. It was plugged in for 24 hrs and would not hold the charge. Rptr tested the pump and found the same problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008895 |
| MDR Report Key | 32060 |
| Date Received | 1996-04-17 |
| Date of Report | 1996-04-11 |
| Date of Event | 1996-04-01 |
| Date Added to Maude | 1996-04-22 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUAM UTERINE ACTIVITY MONITOR |
| Generic Name | UTERINE ACTIVITY MONITOR |
| Product Code | KXO |
| Date Received | 1996-04-17 |
| Returned To Mfg | 1996-04-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 33308 |
| Manufacturer | CORAM HEALTHCARE CORP. |
| Manufacturer Address | 2275 HALF DAY RD BANNOCKBIER IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-04-17 |