MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP-I

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2013

Event Type  Injury  

Event Description

The hls set being used to support the cardiohelp-i was being used from (b)(6) 2013 but then sounded an alarm with message "tart sensor defective." the evening shift confirmed with the user manual that the remedy was to "replace external sensor".An internal sensor cable from a demo unit was used instead.This did not correct the alarm so the original cable was replaced.The cardiohelp unit was swapped out on (b)(6) 2013 with a loaner unit.The pt was off support for 14 seconds.The loaner unit showed no error message.No injury or death reported.(b)(4).

• Brand Name: CARDIOHELP-I
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365184
• MDR Text Key: 5232316
• Report Number: 3008355164-2014-00357
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/16/2014,04/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/05/2013
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention