MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-07 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[3061894]
The quality engineering reported that during evaluation of the device at the laboratory, a mounting bracket was found to be broken. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[10455899]
The complaint was confirmed by laboratory analysis. The product will be sent to service to be brought to manufacturers 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
| Report Number | 1828100-2013-00032 |
| MDR Report Key | 2907017 |
| Report Source | 07 |
| Date Received | 2013-01-07 |
| Date of Report | 2012-12-12 |
| Date of Event | 2012-12-12 |
| Date Mfgr Received | 2012-12-12 |
| Date Added to Maude | 2013-03-29 |
| 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 | 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 | 2013-01-07 |
| Returned To Mfg | 2012-12-12 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | OTHER |
| 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 | 2013-01-07 |