MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for CARESTREAM VUE RIS 7119 manufactured by Carestream Health Inc..
[129199593]
The carestream vue ris operated as designed and expected and did not cause this event. The root cause was identified in the integration software used to convert the information in a standard medical device format (dicom) to the non medical device system format of hl7 messages.
Patient Sequence No: 1, Text Type: N, H10
[129199594]
(b)(4). X-ray exam was reported in ris identifying need for urgent follow up action with patient having an identified cancer. The report was passed through hospital it systems and arrived at ice it system with header but no report body. The lack of body meant the ice system did not find a pathway code allowing it to be progressed and so patient treatment did not occur. Clinicians stated the cancer was now terminal due treatment not being provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317307-2018-00005 |
| MDR Report Key | 8093889 |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-10-19 |
| Device Manufacturer Date | 2014-03-14 |
| Date Added to Maude | 2018-11-21 |
| 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 | 1049 RIDGE ROAD |
| Manufacturer City | ROCHESTER NY 14615 |
| Manufacturer Country | US |
| Manufacturer Postal | 14615 |
| Manufacturer Phone | 1442430051 |
| Manufacturer G1 | CARESTREAM HEALTH INC |
| Manufacturer Street | 1049 RIDGE ROAD |
| Manufacturer City | ROCHESTER NY 14615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARESTREAM VUE RIS |
| Generic Name | VUE RIS |
| Product Code | LMD |
| Date Received | 2018-11-21 |
| Model Number | VUE RIS |
| Catalog Number | 7119 |
| 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 | 2018-11-21 |