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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.Getinge service has not been requested by the customer, so we are unable to complete an evaluation.If provided, we will send a supplemental report with our additional findings.Not returned to manufacturer.
 
Event Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) did not alarm.Three hours after the intra-aortic balloon (iab) was inserted, when the iabp display was confirmed, the diastolic augmentation pressure hardly increased, and the iab pressure waveform increased only about half of the normal pressure.No alarm sounds.The alarm was not muted.When the iab was refilled, it started working without problems.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A getinge service representative reported that there were no anomalies or malfunction reported from the customer.Thus any repair for this iabp unit was not required.
 
Event Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) did not alarm.Three hours after the intra-aortic balloon (iab) was inserted, when the iabp display was confirmed, the diastolic augmentation pressure hardly increased, and the iab pressure waveform increased only about half of the normal pressure.No alarm sounds.The alarm was not muted.When the iab was refilled, it started working without problems.No patient harm, serious injury or adverse event was reported.
 
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Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10267681
MDR Text Key198699691
Report Number2249723-2020-01073
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3013-65
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
YAMATO PLUS-R 30CC; YAMATO PLUS-R 30CC
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