MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for VIVIDIMAGE 27" HD SURGICAL MONITOR manufactured by Black Diamond Video.
[119935537]
Following the reported event, the user facility's biomed service team inspected the surgical monitor. The service team observed fluid intrusion around the monitor's keypad membrane. Based on the description on the event, steris determined that the user facility is not following proper cleaning practices which allowed fluid intrusion to enter the keypad membrane and the reported event to occur. The user facility replaced the monitor's keypad membrane, tested the monitor, confirmed it to be operating according to specifications, and returned it to service. Steris provided in-service training to user facility personnel on proper cleaning practices. The user facility is responsible for all cleaning activities. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[119935538]
The user facility reported that during the start of a patient procedure, their (b)(4) surgical monitor was not operating properly. A procedure delay occurred as user facility personnel replaced the monitor with a second monitor present in the room. No report of injury and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008776287-2018-00006 |
| MDR Report Key | 7851906 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-09-06 |
| 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. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | BLACK DIAMOND VIDEO |
| Manufacturer Street | 503 CANAL BLVD. |
| Manufacturer City | RICHMOND CA 94804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIVIDIMAGE 27" HD SURGICAL MONITOR |
| Generic Name | SURGICAL MONITOR |
| Product Code | KQM |
| Date Received | 2018-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLACK DIAMOND VIDEO |
| Manufacturer Address | 503 CANAL BLVD. RICHMOND CA 94804 US 94804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |