MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for SIEMENS STABILIPLAN manufactured by Siemens Medical Systems.
[4997]
Patient was receiving padiation therapy, a single drop of oil dripped in patients left eye. Eye was flushed with saline by radiation on cologist immediately following incident. Patient was seen and evaluated by ophthalmologist. No reaction was noted with eye by ophthalmologist. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-94. 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: mechanical problem, cable. Conclusion: intermittent failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9060 |
| MDR Report Key | 9060 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-05-06 |
| Date of Event | 1994-04-19 |
| Date Facility Aware | 1994-04-19 |
| Report Date | 1994-05-06 |
| Date Reported to Mfgr | 1994-05-06 |
| Date Added to Maude | 1994-11-18 |
| 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 | SIEMENS |
| Generic Name | ORTHOVOLTAGE |
| Product Code | IYC |
| Date Received | 1994-07-29 |
| Model Number | STABILIPLAN |
| Device Expiration Date | 1990-11-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-NOV-90 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8720 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-29 |