MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-07 for CARESTREAM VUE PACS 1201284 manufactured by Carestream Health.
[182479111]
Carestream received a complaint on (b)(6) 2020 and has started the investigation process. When additional information and facts become available, a follow-up report will be submitted within 30 days.
Patient Sequence No: 1, Text Type: N, H10
[182479112]
The hospital site reported that the carestream vue pacs allegedly contributed to a patient death due to the system being down and patient images not accessible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317307-2020-00001 |
| MDR Report Key | 9803595 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-07 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-07 |
| 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 | MX NANCY MEJIAS |
| Manufacturer Street | 150 VERONA ST |
| Manufacturer City | ROCHESTER, NY |
| Manufacturer Country | US |
| Manufacturer Phone | 6278533 |
| Manufacturer G1 | CARESTREAM HEALTH |
| Manufacturer Street | 1049 RIDGE RD WEST |
| Manufacturer City | ROCHESTER, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARESTREAM VUE PACS |
| Generic Name | VUE PACS |
| Product Code | LLZ |
| Date Received | 2020-03-07 |
| Model Number | VUE PACS |
| Catalog Number | 1201284 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH |
| Manufacturer Address | CARESTREAM HEALTH INC 150 VERONA ST ROCHESTER, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2020-03-07 |