MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 70104.8012# CARDIOHELP-I; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701048012

Device Problem Device Inoperable (1663)

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

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will be investigated by a maquet service technician.A supplemental medwatch will bee submitted as soon as additional information becomes available.

Event Description

It was reported that shortly after initiation of support the cardiohelp was non-responsive to touch input from the user.They tried to recalibrate the touchscreen.The screen could not be interfaced with all despite attempts to do.The customer changed out the cardiohelp for another unit.(b)(4).

Manufacturer Narrative

(b)(4).The device was evaluated by a maquet field service technician who replaced the device touch panel.Full functional tests and safety tests as per the service manual were also performed, all tests passed and the device was returned to service.This is a known issue and an internal corrective and preventive action has been initiated.There was no patient harm reported for this incident.This first follow up report will also serve as a final report for this issue.

Event Description

(b)(4).

• Brand Name: 70104.8012# CARDIOHELP-I
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5570214
• MDR Text Key: 43158443
• Report Number: 8010762-2016-00257
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

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: Health Professional
• Device Model Number: 701048012
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: 03/14/2016
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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