MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; HL 20 CONSOLE BASE

Model Number MCP00702885

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 06/12/2014

Event Type  Injury  

Event Description

It was reported that the device displayed error message "overtemp" and "belt slip" while in use on a pt.Shortly afterwards, the pump felt hot to the touch and shut down.The device was swapped for another.No reported pt effect.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal mfr of the device maquet cardiopulmonary (b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.The device has not yet been evaluated.A supplemental medwatch will be submitted when additional info becomes available.(b)(4).

• Brand Name: MAQUET CARDIOPULMONARY AG
• Type of Device: HL 20 CONSOLE BASE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strabe 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3976266
• MDR Text Key: 4637241
• Report Number: 8010762-2014-00263
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/15/2014,06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00702885
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/16/2014
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2014
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2006
• 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
• Patient Outcome(s): Required Intervention