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

Model Number CARDIOHELP-I

Device Problem Failure to Run on Battery (1466)

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

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

It was reported that the cardiohelp had a battery charging failure.The cardiohelp was exchanged during treatment.No harm to any person has been reported.Complaintnumber: (b)(4).

Manufacturer Narrative

A getinge service technician (fst) was sent for investigation and repair on 2022-09-13/15.The ac power supply and the ac mains connector were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6)) was reviewed on 2022-08-25.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.A follow up will submitted when additional information become available.

Event Description

Complaint number: (b)(4).

Event Description

Complaintnumber: (b)(4).

Manufacturer Narrative

It was reported that the cardiohelp could not charge the batteries even it was plugged into the wall outlet.The failure occurred during treatment.A getinge service technician (fst) was sent for investigation and repair on 2022-09-13/15.The ac power supply and the ac mains connector were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The affected ac mains connector and power supply was investigated by getinge life-cycle-engineering on 2023-01-17 with the following outcome: according to the failure description it was not possible to charge the ch batteries with mains voltage.The failure could be confirmed with the log files and the time frame in which the power supply started to break down could be narrowed down.The damaging of the above stated element prior to the measurements underlines the possibility of an earlier damage as hinted in the log files.The cause for the reported error is the breakdown of the power switch.According to the instruction for use (chapter 5.6.1 "check before every application", point 15) the user should only start the application when the batteries of the cardiohelp are fully charged and calibrated.If not used during transportation the batteries are a backup power supply for the ac/dc power supply via cable.The device history record (dhr) of the cardiohelp (material: 701072780, serial: ((b)(6)) was reviewed on 2022-08-25.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the investigation results the reported "battery charging failure" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue 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.Note: if new relevant information become available, the complaint will be re-opened and further investigation steps will be initiated.

• 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: 15273913
• MDR Text Key: 305418835
• Report Number: 8010762-2022-00333
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1