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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 0998-00-3023-55
Device Problem Low Readings (2460)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse checked the iabp with a trainer for more than one hour without issue.The fse performed all required functional tests.The iabp unit was cleared for clinical use, and released to the customer.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) augmented pressure was lower than the systolic pressure.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
Manufacturer Narrative
Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 12 month product complaint trend data for the period ( dec-2019 to nov-2020 ) was reviewed.There were no triggers identified for the review period.
 
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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 Key10929783
MDR Text Key219359099
Report Number2249723-2020-02046
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567112541
UDI-Public10607567112541
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,foreig
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-3023-55
Device Catalogue Number0998-00-3023-55
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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