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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Break (1069)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2024
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) unit's on off switch is broken.
 
Manufacturer Narrative
Corrected data: b5, b6, b7, d5, d10, e4, g2, h6 (clinical and impact code).Updated data: b4, e1 (initial reporter and email), e2, e3, g3, g6, h2, h10, h11.
 
Event Description
It was reported that during preventative maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) unit's on off switch was found to be not functioning properly, it was broken and blood back tubing was broken.There was no patient involvement.
 
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Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key18516529
MDR Text Key333339241
Report Number2249723-2024-00172
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Date Manufacturer Received01/24/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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