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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Connection Problem (2900)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2022
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, cs300 intra-aortic balloon pump (iabp) unit's ecg didn't have a waveform.The customer changed the console, cables, etc.Three times with no success.It was suggested that the problem was likely a conduction issue based on the troubleshooting attempts.It was recommended that the customer move two of the ecg patches, adding water soluble doppler gel prior to placing them.The customer was also instructed to move two of the electrodes to the patients back and move the other two more anterior.This gave a waveform immediately but a screenshot of the pump's screen showed the ecg still had some artifacts.
 
Event Description
It was reported that during use on a patient, cs300 intra-aortic balloon pump (iabp) unit's ecg didn't have a waveform.The customer changed the console, cables, etc.Three times with no success.It was suggested that the problem was likely a conduction issue based on the troubleshooting attempts.It was recommended that the customer move two of the ecg patches, adding water soluble doppler gel prior to placing them.The customer was also instructed to move two of the electrodes to the patients back and move the other two more anterior.This gave a waveform immediately but a screenshot of the pump's screen showed the ecg still had some artifacts.There was no patient harm or injury reported.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of Device
SYSTEM, 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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key14875763
MDR Text Key303246148
Report Number2249723-2022-01540
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/17/2008
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
INTRA-AORTIC BALLOON PUMP UNIT.
Patient Age75 YR
Patient SexFemale
Patient Weight68 KG
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