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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2021
Event Type  malfunction  
Event Description
It was reported that during patient use, the cs300 intra-aortic balloon pump (iabp) displayed "check iab catheter" alarm and would not pump, after the patient was switched to this replacement iabp unit involved from another cs300 iabp unit, whereby an unrelated issue of an "optical sensor failure" message displayed, the pump stopped at times on it's own and needed to be started again. The initial reporter also reported that the patient was then placed back on the original cs300 iabp unit, at which time, the unit was pumping despite the message "optical sensor failure" that was still displayed. The initial reporter reached out to a third-party technician for help. Moreover, the initial reporter reported that troubleshooting was not attempted as the end users had no training on the iabp units. Furthermore, the initial reporter stated that an english speaking person will not be available to communicate with the getinge representative. The getinge representative informed the initial reporter that a getinge service tech will attempt to speak to the initial reporter, if available. Although it was reported that patient therapy was delayed, there was no harm or injury to the patient and no adverse event was reported. This report is for the second iabp used. The first and final iabp is being reported separately.
 
Manufacturer Narrative
At this time, the customer has not requested getinge to evaluate the iabp. Attempts are being made to obtain additional information with regard to the repair and status of the iabp unit. A supplemental report will be submitted when this information is provided to us. The full address of the event site was shortened due to field character limit; the full address is (b)(6). Patient height 180cm.
 
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Brand NameCS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
MDR Report Key12721685
MDR Text Key282514565
Report Number2249723-2021-02504
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device?

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