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 CS100; 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 CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3013-55
Device Problem Inability to Auto-Fill (1044)
Patient Problem No Patient Involvement (2645)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available.Not returned to manufacturer.
 
Event Description
It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) had an autofill failure.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) had an autofill failure.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Updated fields: h6 (evaluation method codes, result codes, conclusion codes).Corrected fields: d4 (catalog#, unique identifier (udi) #).A getinge field service engineer (fse) reported that the issue was rectified by replacing the defective purge valve assembly.The iabp was returned to the customer and cleared for clinical use.2/11/2021 investigation complete, add conclusion codes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11096003
MDR Text Key224399426
Report Number2249723-2020-02243
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107745
UDI-Public10607567107745
Combination Product (y/n)N
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0998-00-3013-55
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-