MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED manufactured by Ge Medical Systems, Inc..
[174702557]
When attempting to initiate x-ray equipment for scheduled catheter procedure for an urgent catheter, as physician stepped on pedal to activate, x-ray did not come on, despite multiple attempts with pedal. System shut down and restarted and then pedal worked. Clinical engineering called in which i was directed to information systems, information systems paged out to clinical engineering on call and waited for call back. Gary from clinical engineering called back and stated he was at a nearby site and would head over when he was finished. He never showed up. We reset system at end of case and performed an xray test in which the x-ray worked. We were paged in for a myocardial infarction alert- same issue occurred with pedal and start of x-ray. Cath lab supervisor paged and informed of event- she paged clinical engineering again and they arrived after case to change out the xray pedal and assess equipment.
Patient Sequence No: 1, Text Type: D, B5
[177926907]
When attempting to initiate x-ray equipment for scheduled catheter procedure for an urgent catheter, as physician stepped on pedal to activate, x-ray did not come on, despite multiple attempts with pedal. System shut down and restarted and then pedal worked. Clinical engineering called in which i was directed to information systems, information systems paged out to clinical engineering on call and waited for call back. Clinical engineering called back and stated he was at a nearby site and would head over when he was finished. He never showed up. We reset system at end of case and performed an xray test in which the x-ray worked. We were paged in for a myocardial infarction alert- same issue occurred with pedal and start of x-ray. Cath lab supervisor paged and informed of event- she paged clinical engineering again and they arrived after case to change out the xray pedal and assess equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9580386 |
| MDR Report Key | 9580386 |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-11-01 |
| Report Date | 2019-12-23 |
| Date Reported to FDA | 2019-12-23 |
| Date Reported to Mfgr | 2020-01-13 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code | JAA |
| Date Received | 2020-01-13 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3000 N GRANDVIEW BLVD WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |