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

Catalog Number	0998-UC-3013-65
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available.The full name of the event site was shortened due to field character limit; the full name is (b)(6) hospital.Not returned to manufacturer.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) did not power up.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.The fse suspected a connection failure, so the connectors were cleaned and re-connected which were: the flat cable between the video receiver board and the display, the connecting part between the video receiver board and ac-to-dc inverter, the connector between the keypad controller board and the video receiver board, the coiled cord cable and the console.Regarding the power-up failure, the fse reported that it seemed to be caused that this iabp unit was powered on and off repeatedly within 2 seconds.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) did not power up.There was no patient involvement, and no adverse event reported.Additional information was later provided in regards to this reported issue, in which prior to be use on a patient, the iabp was turned on and the monitor displayed normally; however, the patient went into cardiac arrest.The resuscitation for the patient was successful.The patient went into cardiac arrest prior to iabp therapy.When the intra-aortic balloon (iab) catheter was about to be connected to this iabp unit, the monitor had been blacked out.After this iabp unit was turned off and on repeatedly, the iabp unit was able to be re-booted.Then the iab catheter was connected to this iabp unit and cardiopulmonary bypass was taken on the patient.Approximately 10 to 15 minutes after iabp therapy started, the monitor would not be displayed properly.This unit was attempted to be re-booted, but it failed.Another iabp unit was used instead to continue iabp therapy.The patient was being monitored at intensive care unit.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) did not power up.There was no patient involvement, and no adverse event reported.Additional information was later provided in regards to this reported issue, in which prior to be use on a patient, the iabp was turned on and the monitor displayed normally; however, the patient went into cardiac arrest.The resuscitation for the patient was successful.The patient went into cardiac arrest prior to iabp therapy.When the intra-aortic balloon (iab) catheter was about to be connected to this iabp unit, the monitor had been blacked out.After this iabp unit was turned off and on repeatedly, the iabp unit was able to be re-booted.Then the iab catheter was connected to this iabp unit and cardiopulmonary bypass was taken on the patient.Approximately 10 to 15 minutes after iabp therapy started, the monitor would not be displayed properly.This unit was attempted to be re-booted, but it failed.Another iabp unit was used instead to continue iabp therapy.The patient was being monitored at intensive care unit.

• Brand Name: CS100
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10855488
• Report Number: 2249723-2020-01933
• Device Sequence Number: 14523819
• Product Code: DSP
• UDI-Device Identifier: 10607567108674
• UDI-Public: 10607567108674
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0998-UC-3013-65
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/27/2020; 04/02/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 02/15/2021; 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1