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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 Problems Loose or Intermittent Connection (1371); Output below Specifications (3004)
Patient Problem No Patient Involvement (2645)
Event Date 04/27/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp and during an initial external inspection it was seen that the safety disk/condensate removal module was loose.Part was refitted properly and machine powered up - no alarm appeared.Equipment was then put through a basic service in order to confirm pressure/vacuum values.Equipment failed autofill calibration with a value of 49mmhg.Bimba cylinder was adjusted and retested - new value of 100mmhg.Equipment put through a final function test.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
 
Event Description
It was reported that prior to use a "low vacuum alarm" had appeared on a cs300 intra-aortic balloon pump (iabp).Due to the current pandemic crisis it was asked that the machine be removed from current location, cleaned, and quarantined for engineers visit.Upon cleaning the machine on tuesday (b)(6) 2020, it was noticed by the perfusion staff that the gas reservoir was sitting loose.When refitted the machine was turned back on and the alarm failed to show.There was no patient involvement and no adverse event was reported.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10083221
MDR Text Key193432646
Report Number2249723-2020-00785
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/27/2020
Initial Date FDA Received05/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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