• 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 SYSTEM98 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 SYSTEM98 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Alarm Not Visible (1022); Failure to Sense (1559)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this reported event. The getinge field service engineer (fse) advised that the local distributor's engineer performed service repairs to the unit involved in this reported event. Based on the information made known to us, at this time, the reported issue was resolved by replacing the pressure sensing line. The unit was then calibrated, and all functional and safety checks to meet factory specifications were performed. The iabp was then released to the customer and cleared for clinical service. (b)(6).
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an abnormal counterpulsation pressure waveform reading without alarming the end user. It was further reported that the unit's counterpulsation pressure sensor or pressure sensing line was faulty. The end user switched to another iabp unit without any issues or harm to patient. No patient harm, serious injury or adverse event was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYSTEM98
Type of DeviceSYSTEM, 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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11066976
MDR Text Key225785417
Report Number2249723-2020-02218
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108575
UDI-Public10607567108575
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K961509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0446-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/1999
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-