Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-XX
Device Problems Defective Component (2292); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 07/13/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit was reviewed and no non-conformances related to the reported event were noted.Additional information has been requested.A supplemental report will be sent upon receiving this information.(b)(6).
 
Event Description
It was reported that operating mode switches (auto, semi-auto and manual) of the cs300 intra- aortic balloon pump (iabp) were not working after one minutes of being powered on.In addition, the iabp unable to zero pressure, standby mode and alarm mute buttons were non-functional.This is an out of box failure.There was no patient involvement, therefore no adverse event was reported.
 
Event Description
It was reported that operating mode switches (auto, semi-auto and manual) of the cs300 intra- aortic balloon pump (iabp) were not working after one minutes of being powered on.In addition, the iabp unable to zero pressure, standby mode and alarm mute buttons were non-functional.This is an out of box failure.There was no patient involvement, therefore no adverse event was reported.
 
Manufacturer Narrative
Initial mdr (it was later clarified that the aware date of this complaint was july 13, 2018.Therefore, the date entered in the initial mdr was incorrect, and should have been 13-july-2018 opposed to 07-aug-2018.A getinge company representative reported that the iabp unit has been serviced and returned to the customer for clinical use.
 
Manufacturer Narrative
The getinge company representative reported that the authorized getinge distributor has not yet performed the repair of the cs300.They are currently awaiting the shipment of a replacement display assembly in order to complete the needed repairs.The iabp unit has been removed from clinical use, as the facility has 3-4 other units available.A supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported that operating mode switches (auto, semi-auto and manual) of the cs300 intra- aortic balloon pump (iabp) were not working after one minutes of being powered on.In addition, the iabp unable to zero pressure, standby mode and alarm mute buttons were non-functional.This is an out of box failure.There was no patient involvement, therefore no adverse event was reported.
 
Manufacturer Narrative
The suspected faulty oob display assembly was returned to getinge¿s national repair center (nrc) for evaluation.A senior repair technician inspected the display assembly and observed no visual damage.The national repair center installed the display assembly into the cs300 test fixture and tested the board to factory specifications per procedure.The display assembly passed testing.Nrc could not verify the reported failure of unable to zero pressure, auto, semi-auto and manual keypad functions not working one minute after power up.The display ran overnight in cs300 test fixture without a failure.Scrapped and retaining cs300 display assembly in nrc per procedure.
 
Event Description
It was reported that operating mode switches (auto, semi-auto and manual) of the cs300 intra- aortic balloon pump (iabp) were not working after one minutes of being powered on.In addition, the iabp unable to zero pressure, standby mode and alarm mute buttons were non-functional.This is an out of box failure.There was no patient involvement, therefore no adverse event was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key7852825
MDR Text Key119657034
Report Number2249723-2018-01535
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,distri
Type of Report Initial,Followup,Followup,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-3023-XX
Was Device Available for Evaluation? Yes
Device Age YR
Date Manufacturer Received10/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-