MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP

Model Number 70104.8012

Device Problem Device Inoperable (1663)

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

Event Date 05/03/2014

Event Type  Injury  

Event Description

It was reported that while a pt was on a cardiohelp, the touchscreen could not be unlocked.According to the perfusionist, the screen was frozen.The pt had to be hand cranked until he could be put on a backup device.Additionally, the user stated that the hand crank felt wobbly.No adverse pt effects were reported.Reference: (b)(4).Ref.Mfr # 8010762-2014-00215.

• Brand Name: MAQUET CARDIOHELP
• Type of Device: CARDIOHELP
• 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: 3882988
• MDR Text Key: 4424251
• Report Number: 3008355164-2014-00105
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/29/2014,05/03/2014

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
• Device Model Number: 70104.8012
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention