MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-11 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular System Corp.
[18529111]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, a battery error code occurred (code unknown at this time). After further investigation by the user facility, the unit was not holding a charge and battery was leaking. As a result, an alternate battery was employed. No other details regarding the nature of this event were provided.
Patient Sequence No: 1, Text Type: D, B5
[18751729]
Evaluation is in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1828100-2013-00120 |
MDR Report Key | 2961561 |
Report Source | 05,06 |
Date Received | 2013-02-11 |
Date of Report | 2013-01-16 |
Date of Event | 2013-01-16 |
Date Mfgr Received | 2013-01-16 |
Device Manufacturer Date | 2002-10-01 |
Date Added to Maude | 2013-04-01 |
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 | 2013-02-11 |
Returned To Mfg | 2013-02-06 |
Model Number | 100 |
Catalog Number | 100 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TERUMO CARDIOVASCULAR SYSTEM CORP |
Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-02-11 |