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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.Getinge service was not requested in connection with this event.A supplemental report will be submitted if additional information is made available.
 
Event Description
It was reported that while attempting to start support on a patient, the cs300 intra-aortic balloon pump (iabp) would run/start for about a minute and then stop with a "disconnect message", even though all connections were secure.The customer's only back-up iabp was a system 98xt iabp which they swapped to in order to continue therapy.However, the getinge emergency support technician explained to the end user that the system 98xt was at "end of life" about 10 years prior, and getinge was not able to provide service for this unit.The original iabp was sent to the facility bio-med.There was no harm or injury to patient and no adverse event was reported.
 
Manufacturer Narrative
Updated fields: date of report, pma/510k, if follow-up, what type.The customer reported that the iabp was at end of life, therefore the iabp was retired and removed from service.
 
Event Description
It was reported that while attempting to start support on a patient, the cs300 intra-aortic balloon pump (iabp) would run/start for about a minute and then stop with a "disconnect message", even though all connections were secure.The customer's only back-up iabp was a system 98xt iabp which they swapped to in order to continue therapy.However, the getinge emergency support technician explained to the end user that the system 98xt was at "end of life" about 10 years prior, and getinge was not able to provide service for this unit.The original iabp was sent to the facility bio-med.There was no harm or injury to patient and no adverse event was reported.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8547340
MDR Text Key143846568
Report Number2249723-2019-00659
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,Followup
Report Date 06/21/2019
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 NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/01/2019
Initial Date FDA Received04/24/2019
Supplement Dates Manufacturer Received06/05/2019
Supplement Dates FDA Received06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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