MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AHCT

Device Problem Impedance Problem (2950)

Patient Problem Not Applicable (3189)

Event Date 05/21/2014

Event Type  malfunction  

Event Description

The service repair tech (srt) reported that during routine testing of the device at the service center, the blood parameter monitor (bpm) failed the high potential (hi-pot) test.There was no pt involvement.

Manufacturer Narrative

The reported complaint was confirmed by the service repair tech (srt).The srt identified the bpm was creating a leakage to ground during testing.The arterial bpm sensor was replaced and the unit completed testing before being returned to clinical use.If add'l info becomes available on this complaint that could alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3915784
• MDR Text Key: 4517120
• Report Number: 1828100-2014-00477
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1