MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-16 for CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM DRX R-1 1019397 manufactured by Carestream Health Inc.
[133192510]
Per the investigation, there was no device malfunction. This issue was caused by the technician placing the lead marker on the incorrect side of the image. This lead to the chest tube being placed on the incorrect side.
Patient Sequence No: 1, Text Type: N, H10
[133192511]
Carestream health received a report related to a chest tube being placed on the incorrect side of the patient. Reporters narrative: an ap (anteroposterior) one view chest was taken and the image came up as pa (posterioranterior). The tech stated that the right lead marker was either collimator out or masked out, unsure. Tech then added a digital left marker on what she thought was the left side. But this was not correct because the image was flipped. The image was sent to the radiologist to be read who did not catch this error and read it incorrectly. The er (emergency room) physician read the image and placed a chest tube on the incorrect side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317307-2019-00001 |
| MDR Report Key | 8252264 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-12-24 |
| Date Mfgr Received | 2018-12-31 |
| Date Added to Maude | 2019-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR LEE MILLWARD |
| Manufacturer Street | 150 VERONA STREET |
| Manufacturer City | ROCHESTER 14608 |
| Manufacturer Country | US |
| Manufacturer Postal | 14608 |
| Manufacturer G1 | CARESTREAM HEALTH INC |
| Manufacturer Street | 1049 RIDGE ROAD |
| Manufacturer City | ROCHESTER 14615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14615 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM |
| Generic Name | DRX REVOLUTION |
| Product Code | IZL |
| Date Received | 2019-01-16 |
| Model Number | DRX R-1 |
| Catalog Number | 1019397 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH INC |
| Manufacturer Address | 150 VERONA STREET ROCHESTER NY 14608 US 14608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-16 |