MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Loss of Power (1475); Installation-Related Problem (2965)

Patient Problem Ventricular Tachycardia (2132)

Event Date 09/30/2017

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.Our field service engineer (fse) performed running test on the iabp.The incident reported was duplicated.The result of running test is that our fse suspects the replaced new solenoid driver board to be the problem and this was replaced.Further running test were performed without generating any problem.However, a return of the iabp has been requested for further evaluation by the manufacturer.A supplemental report will be submitted when more information becomes available.The full name of the event site is national cerebral and cardiovascular center, but was shortened due to the field character limit.

Event Description

Customer reported that during patient therapy on the critical care unit (ccu), the patient¿s condition got worse.At this stage, the patient had ventricular tachycardia (vt) and the intra-aortic balloon pump (iabp) had been shut down when the nurse came in.Although there were attempts to restart the iabp, the iabp did not restart.The iabp was replaced with another iabp to continue therapy.This event occurred after the new solenoid driver board was installed under the current field service corrective action.However, there was no patient death reported.

Manufacturer Narrative

The supplier verified the failure.The root cause of the failure was determined to be a shorted capacitor.The supplier replaced the shorted capacitor c80 and the board passed all of their testing.The getinge national repair center (nrc) tested the board to factory specifications per cs100 service manual and the board also passed testing.The board is being scrapped and retained in the nrc per procedure.

Event Description

Customer reported that during patient therapy on the critical care unit (ccu), the patient¿s condition got worse.At this stage, the patient had ventricular tachycardia (vt) and the intra-aortic balloon pump (iabp) had been shut down when the nurse came in.Although there were attempts to restart the iabp, the iabp did not restart.The iabp was replaced with another iabp to continue therapy.This event occurred after the new solenoid driver board was installed under the current field service corrective action.However, there was no patient death reported.

Manufacturer Narrative

Our national repair center (nrc) performed inspection of the solenoid driver board and no visual damage was observed.The nrc then installed the solenoid driver board into the cs100 test fixture and tested the module to factory specification per service manual and verified the reported failure ¿pump does not power up¿.The nrc has sent the board to the supplier for failure analysis per procedure.

Event Description

Customer reported that during patient therapy on the critical care unit (ccu), the patient¿s condition got worse.At this stage, the patient had ventricular tachycardia (vt) and the intra-aortic balloon pump (iabp) had been shut down when the nurse came in.Although there were attempts to restart the iabp, the iabp did not restart.The iabp was replaced with another iabp to continue therapy.This event occurred after the new solenoid driver board was installed under the current field service corrective action.However, there was no patient death reported.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6968780
• MDR Text Key: 89958535
• Report Number: 2249723-2017-00684
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2007
• 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 Outcome(s): Life Threatening
• Patient Age: 55 YR