MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-30 for TERUMO CDI 101 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[2760421]
It was reported that during use of the device for a cardiopulmonary bypass procedure, the screen of unit displayed a "line" across the screen during operation and the function of monitor is "ok. " the customer smelled smoke coming from the monitor. The monitor was shut down and replaced. As a result, an alternate device was employed. The surgical procedure was completed successfully, and there were no delays, no blood loss, or no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[10016569]
The customer's engineer later turned on the unit. After the monitor was on for one hour, smoke could be smelled coming from the monitor and the monitor was shut down. The reported complaint was confirmed. The service repair tech (srt) observed line across screen and a burning smell at startup. The srt found that the inverter pcba had a shorted capacitor. The capacitor was burnt as well as the wires on the inverter pcba to omni pcba cable. The srt replaced the inverter pcba and inverter pcba to omni pcba cable. With the components replaced, the unit operated to manufacturer specifications and was returned to clinical use. Based on a review of the investigation details (smelled smoke being related to burnt wires and shorted capacitor), is considered mdr reportable. This complaint record is more than two years old and is being reported as a result of a health hazard evaluation. If additional info 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
| Report Number | 1828100-2012-01172 |
| MDR Report Key | 2724669 |
| Report Source | 01,07 |
| Date Received | 2012-08-30 |
| Date of Report | 2009-09-23 |
| Date of Event | 2009-07-31 |
| Date Mfgr Received | 2009-09-23 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-12-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIP DURBIN |
| Manufacturer Street | 6200 JACKSON RD. |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO CDI 101 MONITOR |
| Product Code | DTY |
| Date Received | 2012-08-30 |
| Returned To Mfg | 2009-10-09 |
| Model Number | 101 |
| Catalog Number | 101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-30 |