MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-05 for MARQUETTE 7500 SERIES 90041-201;9466-004 manufactured by Marquette Electronics.
[1045]
A patient was on continuous telemetry monitoring. The alarm had been turned off. On 8/21/92 at 1313, the patient was found pulseless and unresponsive. Advanced life support was administered for 31 minutes but was unsuccessful and the patient expireddevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jan-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: design - human factors. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451 |
| MDR Report Key | 1451 |
| Date Received | 1992-10-05 |
| Date of Report | 1992-09-23 |
| Date of Event | 1992-08-21 |
| Date Facility Aware | 1992-08-21 |
| Report Date | 1992-09-23 |
| Date Reported to FDA | 1992-09-23 |
| Date Reported to Mfgr | 1992-09-11 |
| Date Added to Maude | 1992-10-14 |
| 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 | MARQUETTE 7500 SERIES |
| Generic Name | TELEMETRY MONITOR |
| Product Code | GYE |
| Date Received | 1992-10-05 |
| Model Number | 7500 SERIES |
| Catalog Number | 90041-201;9466-004 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-DEC-90 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1394 |
| Manufacturer | MARQUETTE ELECTRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1992-10-05 |