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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
The customer has not requested getinge to evaluate the iabp in connection with this event.Good faith efforts (gfe) attempts are being made to the customer to obtain information on this complaint event.If pertinent information is received, then a supplemental report will be submitted.Not returned to manufacturer.
 
Event Description
It was reported the helium depleted and there was no low helium alarm in the cardiosave intra-aortic balloon pump (iabp).It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
Event Description
It was reported the helium depleted and there was no low helium alarm in the cardiosave intra-aortic balloon pump (iabp).It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10877468
MDR Text Key219503835
Report Number2249723-2020-01984
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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