MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-11 for COMPUMED MEDICATION DISPENSER manufactured by Compumed.
[14221]
Did not alarm properly. Pt did not receive medication on 10/1/95. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: none or unknown. Conclusion: device failed during assembly. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 27710 |
| MDR Report Key | 27710 |
| Date Received | 1995-10-11 |
| Date of Report | 1995-10-10 |
| Date of Event | 1995-10-01 |
| Date Facility Aware | 1995-10-01 |
| Report Date | 1995-10-10 |
| Date Reported to FDA | 1995-10-10 |
| Date Reported to Mfgr | 1995-10-09 |
| Date Added to Maude | 1995-11-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPUMED MEDICATION DISPENSER |
| Generic Name | MEDICATION DISPENSER |
| Product Code | NXB |
| Date Received | 1995-10-11 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 01-MAR-95 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 28627 |
| Manufacturer | COMPUMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-10-11 |