MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP-I; DTQ

Device Problem Failure to Run on Battery (1466)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

This report is being generated as a result of info provided in an email from (b)(6) on (b)(6) 2013.The comments follow: "has anyone had issues with the following? maquet cardiohelp battery failure.We have had several instances of battery failure, one was a complete shutdown of pump while patient was on, after it was unplugged for transport".These comments were made in a blog by the following staff perfusionist at (b)(6).

• Brand Name: CARDIOHELP-I
• Type of Device: DTQ
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4365351
• MDR Text Key: 16448645
• Report Number: 3008355164-2014-00384
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2014,12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/26/2013
• Event Location: Hospital
• Date Report to Manufacturer: 12/26/2013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention