MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Service of the affected cardiohelp is anticipated but still pending.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that touchscreen was not responding to touch.A getinge service technician walked the customer through recalibration of the touch screen via video call with cardiohelp responding to touch with no issues post calibration.The patient support was stopped for calibration.No indication for harm to any person.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the touch panel was not responding.The cardiohelp was stopped to perform the touch screen calibration.A getinge service technician investigated the unit on 2021-08-30 and could confirm the failure.The user interface was replaced to restore function.The technician performed safety, calibration, and functionality checks to factory specifications.The root cause for the reported cardiohelp failure "touch panel is not responding" is known.The touch panel foil ((b)(4)) which was used formerly and was affected in this case showed an increased rate of connection problems.As a solution for that a new touch panel was implemented and is built in cardiohelp units since september, 2019.In regards to the replacement of this part a service bulletin (issue 82 / 2019-09-25) was provided to the sales and service units.Based on the investigation results the reported failure "touch not responding" could be confirmed.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12243868
• MDR Text Key: 264041029
• Report Number: 8010762-2021-00417
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701072780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1