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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 Problem Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2019
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 the battery of the cs300 intra-aortic balloon pump (iabp) died before leaving the department.The iabp was plugged in and indicators showed it was fully charged.The facility's biomedical engineer confirmed that the device was showing as fully charged.As soon as the device was unplugged from outlet power, the device began to rapidly lose charge and the pump lost all power within 6 minutes.It is unknown if there was any patient involvement; however there was no adverse event reported.
 
Event Description
It was reported that the battery of the cs300 intra-aortic balloon pump (iabp) died before leaving the department.The iabp was plugged in and indicators showed it was fully charged.The facility's biomedical engineer confirmed that the device was showing as fully charged.As soon as the device was unplugged from outlet power, the device began to rapidly lose charge and the pump lost all power within 6 minutes.It is unknown if there was any patient involvement; however there was no adverse event reported.
 
Manufacturer Narrative
The customer bio med replaced the battery and repaired the unit.All functional and safety tests were passed to factory specifications.Iabp was then returned to customer and cleared for clinical use.
 
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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 Key9535842
MDR Text Key190765053
Report Number2249723-2019-02124
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 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
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
Date Manufacturer Received01/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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