MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-30 for CDI BLOOD PARAMETER MONITORING SYSTEM 500 500AVHCT manufactured by Terumo Cardiovascular Systems Corporation.
[146544831]
The srt replaced the defective lcd backlight driver. The unit operated to the manufacturer's specifications. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[146544832]
The service repair technician (srt) reported that during routine testing of the device at the service center, the damaged liquid crystal display (lcd) back light driver is causing smoke and a blank display while turning on the unit. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2019-00285 |
| MDR Report Key | 8655558 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-30 |
| Date of Report | 2019-10-24 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-10-08 |
| Device Manufacturer Date | 2017-02-21 |
| Date Added to Maude | 2019-05-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DOUGLAS PATTON |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
| Generic Name | MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500 |
| Product Code | DRY |
| Date Received | 2019-05-30 |
| Model Number | 500AVHCT |
| Catalog Number | 500AVHCT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-30 |