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

Model Number 500AHCTR

Device Problem Circuit Failure (1089)

Patient Problem Not Applicable (3189)

Event Date 04/09/2014

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed by the product surveillance technician.During the laboratory evaluation when the blood parameter monitor (bpm) began to power up, a rapidly repeating beeping tone was heard along with a popping sound and an overheating smell.The capacitor at c94 of the aux board failed.The product will be sent to service to be brought to manufacturer's 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.

Event Description

The product surveillance technician reported that during routine testing of the device at the service center, a capacitor (c94) failed on the aux printed circuit board assembly (pcba) of the blood parameter monitor (bpm).There was no patient involvement.

• Brand Name: TERUMO CDI 500 BLOOD SUGAR 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: 3900141
• MDR Text Key: 21157538
• Report Number: 1828100-2014-00348
• 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: 04/09/2014

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: 500AHCTR
• Device Catalogue Number: 500AHCTR
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2001
• 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