MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for MDRC-1119 WITH PROTECTIVE COVER KIT MDRC-1119 PROTECTIVE COVER KIT C9826109 manufactured by Barco Nv.
[68768623]
The display nor its front cover were returned to the manufacturer. However based on photographs and other information from the customer and in-house testing it was concluded that the metal strips that are applied (glued) to the display for fixation of the cover, were clearly re-used. As a result the strips are not flat but bended, resulting in a decreased contact surface with the front cover. It is obviously not the intention to re-use the fixation strips but this was not specifically indicated in the installation instructions. A specific warning will be added in the installation instructions.
Patient Sequence No: 1, Text Type: N, H10
[68768624]
During usage of the system, the front cover detached from the display and hit the patient on the cheek. A moderate injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613188-2017-00002 |
| MDR Report Key | 6359988 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-02 |
| Date Mfgr Received | 2016-12-21 |
| Date Added to Maude | 2017-02-27 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR LIEVEN DE WANDEL |
| Manufacturer Street | BENELUXPARK 21 |
| Manufacturer City | KORTRIJK, 8500 |
| Manufacturer Country | BE |
| Manufacturer Postal | 8500 |
| Manufacturer Phone | 56 233459 |
| Manufacturer G1 | BARCO |
| Manufacturer Street | PRESIDENT KENNEDYPARK 35 |
| Manufacturer City | KORTRIJK, 8500 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | 8500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MDRC-1119 WITH PROTECTIVE COVER KIT |
| Generic Name | CLINICAL REVIEW DISPLAY |
| Product Code | PGY |
| Date Received | 2017-02-27 |
| Model Number | MDRC-1119 PROTECTIVE COVER KIT |
| Catalog Number | C9826109 |
| Lot Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARCO NV |
| Manufacturer Address | BENELUXPARK 21 KORTRIJK, 8500 BE 8500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly | 2017-02-27 |