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

Model Number 70104.8012

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, at (b)(6) hospital, for cardiohelp unit (b)(4).The customer reported receiving a "battery 1 needs service" message that appeared after calibration and that while transporting a patient the battery depleted and the machine was not able to run at all.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).An investigation report was submitted by maquet to the saudi fda for the complaint.The report verified that the batteries were working and the reported problem was not reproducible.The report concluded that the error was related to a software problem.(b)(4).

• Brand Name: CARDIOHELP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4931032
• MDR Text Key: 6052815
• Report Number: 8010762-2014-00952
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.8012
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2013
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2013
• Date Manufacturer Received: 11/21/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0211-2015
• Patient Sequence Number: 1