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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 02/18/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided.A getinge field service engineer service rep was contacted and he will schedule a visit.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
 
Event Description
The customer reported that they are having a problem with the pop-up pedestal on the transport part of the cardiosave intra-aortic balloon pump (iabp).It constantly comes loose and causes it to not stay locked down which allows it to pop-up while in the cradle causing it to become stuck.The customer reported that they have tightened it so many times that the screw are starting to become stripped.There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
The customer has not requested getinge to evaluate the iabp in connection with this event.However, the customer has advised that their aircraft mechanic was able to fix the problem.
 
Event Description
The customer reported that they are having a problem with the pop-up pedestal on the transport part of the cardiosave intra-aortic balloon pump (iabp).It constantly comes loose and causes it to not stay locked down which allows it to pop-up while in the cradle causing it to become stuck.The customer reported that they have tightened it so many times that the screw are starting to become stripped.There was no patient involvement and no adverse event was reported.
 
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Brand Name
CARDIOSAVE RESCUE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8422041
MDR Text Key139055647
Report Number2249723-2019-00401
Device Sequence Number1
Product Code DSP
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 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Device Age YR
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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