MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for K58000220 manufactured by Carestream Health, Inc..
[185223722]
Called to icu for line placement portable chest x-ray (pcxr), left dept after next pt. Around 10 min later with port 6 image taken, appeared on screen, but turned red and failed to send. Detector could not be selected to take a new image a different machine was used, and image taken successfully total time taken to complete pcxr was about 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888505 |
| MDR Report Key | 9888505 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-07 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| 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 | 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, MOBILE |
| Product Code | IZL |
| Date Received | 2020-03-27 |
| Model Number | K58000220 |
| Lot Number | 2461 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH, INC. |
| Manufacturer Address | 1049 WEST RIDGE ROAD ROCHESTER NY 14615 US 14615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |