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 09/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).After the mentioned issue the customer performed a touch screen calibration on the affected cardiohelp.The calibration restored the functionality of the device.The customer requested service.Field safety technician has been sent for investigation and performed a touch screen calibration and reviewed the error logs.According to service order (b)(4): cardiohelp is functioning to factory specs after the touch screen recalibration.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.Thus the failure could not be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at these time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.A supplemental report will be provided if additional information becomes available.

Event Description

Customer reported, that the user could not navigate through the various menus of the user interface, because the touch screen was not responding.The hospital decided to swap the unit with another cardiohelp.Issue occurred during patient treatment.No further problems or harm to the patient was reported.(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: 6026609
• MDR Text Key: 57798383
• Report Number: 8010762-2016-00627
• 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
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2016

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
• Device Age: YR
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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 Age: 59 YR