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

Model Number 500AHCT

Device Problems Circuit Failure (1089); Device Emits Odor (1425)

Patient Problem Not Applicable (3189)

Event Date 10/14/2013

Event Type  malfunction  

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the blood parameter monitor (bpm) lost power and would not power up.The unit was being treated for pressure calibration and it shut itself off and would not turn on.A burning smell was noticed from the bpm as well.There was no patient involvement.

Manufacturer Narrative

This complaint was confirmed on the defective printed circuit board assembly (pcba).The service repair technician (srt) identified the aux pcba was defective.The aux pcba was defective.The uax pcba was replaced and the unit completed testing before being returned to clinical use.The defective aux pcba was further evaluated by the laboratory.Laboratory evaluation could not verified nor duplicate the burning smell.The pcba was placed on the platter in the evaluation laboratory and the unit would not allow power up.The circuit board assembly (pcba) was powered up for thirty minutes with no evidence of a burning smell from the pcba and no components were found to be overheating.If additional information becomes available on this complaint that would 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: 3736477
• MDR Text Key: 4278700
• Report Number: 1828100-2014-00071
• 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: 10/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/04/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2013
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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