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

Model Number 70104.8012

Device Problem Device Inoperable (1663)

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

Event Date 01/23/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, it was reported that cardiohelp (serial number (b)(4)) touchscreen was not functioning while the unit was inuse at (b)(6) hospital.The perfusionist could not get the lab menu to appear.The perfusionist contacted another perfusionist for assistance; the other perfusionist was able to change from or to ism application.It was identified that the buttons on the touchscreen would not work unless the screen was touched 1/4" -1" lower.No adverse effects were reported.In summary, the calibration of the touch display drifted to 2.5 cm from setpoint.Reference: complaint (b)(4).

Manufacturer Narrative

(b)(4).On 03/27/2013, service order (b)(4) was generated for the software upgrade from rev.03.03.00 to rev.03.03.02 as a part of the field correction.An inspection was performed and user configurations were verified.The unit passed all function tests to factory specification.Reference: complaint (b)(4).

• Brand Name: CARDIOHELP SYSTEM
• Type of Device: HEART-LUNG,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 ; maquet medical system, usa; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4279867
• MDR Text Key: 15321217
• Report Number: 8010762-2014-00681
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2013

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: 70104.8012
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2013
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2013
• Initial Date Manufacturer Received: 01/23/2013
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2012
• 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