MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-21 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[2761138]
It was reported that the numbers displayed on the monitor are no longer accurate. No other details regarding the nature of this event were provided.
Patient Sequence No: 1, Text Type: D, B5
[10030480]
Lab analysis found the unit failed the color chip test and has a defective opto probe related to the age of the device. No parts are available for repair. 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 | 1828100-2012-01100 |
| MDR Report Key | 2711116 |
| Report Source | 05,06 |
| Date Received | 2012-08-21 |
| Date of Report | 2012-07-26 |
| Date of Event | 2012-07-26 |
| Date Mfgr Received | 2012-07-26 |
| Date Added to Maude | 2012-12-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIPP 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 100 MONITOR |
| Product Code | DTY |
| Date Received | 2012-08-21 |
| Returned To Mfg | 2012-07-31 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-08-21 |