MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-12 for CDI BLOOD PARAMETER MONITORING SYSTEM 500 500AHCT manufactured by Terumo Cardiovascular Systems Corporation.
[139105053]
The reported complaint was identified during unit check-up. During laboratory analysis, the product surveillance technician (pst) observed that the monitor would not power on because of defective auxiliary (aux) board. The aux board was found to have an overheated capacitor. The product will be sent to service to be brought to manufacturer? S specifications before being returned to the customer. 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
[139105054]
It was reported that during the use of the device for a non-clinical activity, the blood parameter monitor (bpm) had no power and would not boot up. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2019-00125 |
| MDR Report Key | 8414155 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2004-06-24 |
| Date Added to Maude | 2019-03-12 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 2019-03-12 |
| Returned To Mfg | 2019-01-24 |
| Model Number | 500AHCT |
| Catalog Number | 500AHCT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-03-12 |