• 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 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V 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 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-55
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Event Description
It was reported that during a routine check it was observed that the cs100 intra-aortic balloon pump (iabp) had a defective ecg interface cable. There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Testing of actual/suspected device ((b)(4)): a getinge field service engineer (fse) evaluated the iabp unit and found that "the ecg interface cable is damaged. The connector plugged into the iabp is broken by the external ecg signal connector from the monitor. To fix the issue the fse repaired the broken device inside of the iabp unit and replaced the ecg interface cable with spare parts that the customer had. The fse performed all system checks of the iabp and came back as normal. Tested the use of the machine and it can be used but there are expired parts that need to be replaced. The customer will make a quote for the expired parts at a later time. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key14242261
MDR Text Key290450585
Report Number2249723-2022-00957
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3013-55
Device Catalogue Number0998-00-3013-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

-
-