MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-13 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[19922538]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the battery was dead on the blood parameter monitor (bpm). 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 patient.
Patient Sequence No: 1, Text Type: D, B5
[20405762]
Eval is in progress, but not yet concluded. The customer stated that he didn't feel comfortable shipping the battery to the manufacturer because it had evidence of a leak.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1828100-2013-00865 |
MDR Report Key | 3396423 |
Report Source | 05,06 |
Date Received | 2013-09-13 |
Date of Report | 2013-09-06 |
Date of Event | 2013-08-01 |
Date Mfgr Received | 2013-09-06 |
Device Manufacturer Date | 1996-03-01 |
Date Added to Maude | 2013-12-19 |
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 | JAN WINDER |
Manufacturer Street | 6200 JACKSON RD. |
Manufacturer City | ANN ARBOR MI 48103 |
Manufacturer Country | US |
Manufacturer Postal | 48103 |
Manufacturer Phone | 7346634145 |
Manufacturer G1 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
Manufacturer Street | 6200 JACKSON RD. |
Manufacturer City | ANN ARBOR MI 48103 |
Manufacturer Country | US |
Manufacturer Postal Code | 48103 |
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 | 2013-09-13 |
Returned To Mfg | 2013-08-16 |
Model Number | 100 |
Catalog Number | 100 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
Manufacturer Address | 6200 JACKSON RD. ANN ARBOR MI 48103 US 48103 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-09-13 |