MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-29 for RADIOMETER-COPENHAGEN AND ELECTRODE ANALYZER ABL 505 manufactured by Radiometer-copenhagen.
[15007709]
Patient's potassium level was 5. 1 on this machine. Same sample sent to main lab was 5. 8. Required patient to receive albumin and medication to decrease potassium leveldevice 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-aug-92. Service provided by: distributor. Service records available. No imminent hazard to public health claimed. 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: electrode. Conclusion: intermittent failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, device use continued with restrictions/limitations, inserviced by manufacturer/distributor representative. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2813 |
| MDR Report Key | 2813 |
| Date Received | 1993-01-29 |
| Date of Report | 1992-08-27 |
| Date of Event | 1992-08-15 |
| Date Facility Aware | 1992-08-19 |
| Report Date | 1992-08-27 |
| Date Reported to FDA | 1992-08-27 |
| Date Reported to Mfgr | 1992-08-27 |
| Date Added to Maude | 1993-03-30 |
| 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 | RADIOMETER-COPENHAGEN |
| Generic Name | BLOOD GAS |
| Product Code | CCC |
| Date Received | 1993-01-29 |
| Model Number | AND ELECTRODE ANALYZER |
| Catalog Number | ABL 505 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-JUN-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2639 |
| Manufacturer | RADIOMETER-COPENHAGEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-01-29 |