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 CORP. - 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 CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Electrical /Electronic Property Problem (1198); Protective Measures Problem (3015)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2019
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.A supplemental report will be submitted when additional information is provided.(b)(6).
 
Event Description
It was reported that on start up the cs300 intra-aortic balloon pump (iabp) displayed "electrical test fails code# 50¿.The facility's service engineer reported that the motor control board (0671-00-0004) was exchanged with a new one from another iabp and the original iabp ran normally.There was no harm or injury to patient and no adverse event was reported.
 
Manufacturer Narrative
Corrected dhr statement from initial report the production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.
 
Event Description
It was reported that during service test by the customer, the cs300 intra-aortic balloon pump (iabp) displayed "electrical test fails code# 50¿.The facility's service engineer reported that the motor control board was exchanged with a new one from another iabp and the original iabp ran normally.There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
A getinge representative evaluated the iabp and was able to reproduce the reported issue.To address it, the getinge representative replaced the motor control board and performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.The suspected faulty board was returned to getinge¿s national repair center (nrc) for evaluation.A senior technician evaluated the board and no visual damage was observed.The technician installed the board into the cs300 test fixture and it tested to factory investigations per cs300 service manual.The nrc verified the reported failure of "electrical test fails code #50".The senior repair technician sent the part to supplier for failure analysis as per procedure.The supplier did not return the defective board and verified that the board drives motor in reverse @2000rpm.Their root cause of failure states "component failure is source of issue" root cause is under investigation.Replaced defective board with a new one.The supplier stated via email "the failure appears to show up in u3, pin#6.However, this may not mean that the failure is there.This is just where it shows an irregular reading".Board below is not the board sent in for failure analysis.It was sent in as a warranty replacement for the defective board sent in for failure investigation.The senior technician of the nrc installed the new board into cs300 test fixture and tested to factory specifications per cs300 service manual.Passed testing.
 
Event Description
It was reported that on start up the cs300 intra-aortic balloon pump (iabp) displayed "electrical test fails code# 50¿.The facility's service engineer reported that the motor control board (0671-00-0004) was exchanged with a new one from another iabp and the original iabp ran normally.There was no harm or injury to patient and 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 CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8562340
MDR Text Key143858447
Report Number2249723-2019-00691
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,foreig
Type of Report Initial,Followup,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3023-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Device Age YR
Date Manufacturer Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-