MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-14 for CDI BLOOD PARAMETER MONITORING SYSTEM 500 850019 manufactured by Terumo Cardiovascular Systems Corporation.
[138948904]
The srt replaced the aux pcba board. The unit operated to the manufacturer's specifications. The suspect device was sent to the laboratory for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[138948905]
The service repair technician (srt) reported that during routine testing of the device at the service center, the capacitor at location c132 on the auxiliary (aux) printed circuit board assembly (pcba) had blown up when the unit was powered up. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2019-00128 |
| MDR Report Key | 8422150 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-14 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-06-14 |
| Date Added to Maude | 2019-03-14 |
| 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 | 2019-03-14 |
| Model Number | 850019 |
| Catalog Number | 850019 |
| Device Availability | Y |
| 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 | 2019-03-14 |