MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-02-19 for ECG MONITOR 705 PATIENT MONITOR manufactured by Biomedical Systems, Inc. (bill Driscoll).
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Patient monitor and oximeter connected together for use. Nursing was told by the physician attending this baby to turn off the alarmsdevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jun-91. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, failure to follow instructions, unanticipated adverse reaction - short term, alarm failure. Conclusion: no failure detected and product within specification, user error contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 111 |
| MDR Report Key | 111 |
| Date Received | 1992-02-19 |
| Date of Report | 1992-01-31 |
| Date of Event | 1992-01-22 |
| Date Facility Aware | 1992-01-24 |
| Report Date | 1992-01-31 |
| Date Reported to FDA | 1992-01-31 |
| Date Reported to Mfgr | 1992-01-31 |
| Date Added to Maude | 1992-03-27 |
| 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 | ECG MONITOR |
| Product Code | LOS |
| Date Received | 1992-02-19 |
| Model Number | 705 PATIENT MONITOR |
| ID Number | M779 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-JUN-91 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 109 |
| Manufacturer | BIOMEDICAL SYSTEMS, INC. (BILL DRISCOLL) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1992-02-19 |