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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Output below Specifications (3004)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2020
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during use on a patient a "low vacuum" alarm occurred on a cs300 intra-aortic balloon pump (iabp).The end user stated that the patient was slightly tachycardic at times but never exceeded 112bpm and also stated the alarm had occurred a few times in the last couple of hours.Getinge customer support (gcr) suggested swapping out to another console and tagging this unit to be tested by biomedical engineering.The nurse stated he had another cs300 readily available, and the gcr reviewed transitioning to another unit to reduce downtime of therapy.The nurse verbalized his confidence in doing so and verbalized that there was no harm to the patient because of this issue.
 
Manufacturer Narrative
Additional information was requested from the customer with regard to the repair and status of the iabp.The customer reported that they evaluated the iabp unit and were able to reproduce the reported issue.They discovered that k6 would intermittently activate while pumping which could be heard.After some troubleshooting, the sd and pump assembly were ruled out and the drive assembly was replaced to fix the issue.The faulty drive assembly reproduced low vacuum alarms and intermittent k6 activation.The iabp was then put back in clinical service.
 
Event Description
It was reported that during use on a patient a "low vacuum" alarm occurred on a cs300 intra-aortic balloon pump (iabp).The end user stated that the patient was slightly tachycardic at times but never exceeded 112bpm and also stated the alarm had occurred a few times in the last couple of hours.Getinge customer support (gcr) suggested swapping out to another console and tagging this unit to be tested by biomedical engineering.The nurse stated he had another cs300 readily available, and the gcr reviewed transitioning to another unit to reduce downtime of therapy.The nurse verbalized his confidence in doing so and verbalized that there was no harm to the patient because of this issue.
 
Event Description
It was reported that during use on a patient a "low vacuum" alarm occurred on a cs300 intra-aortic balloon pump (iabp).The end user stated that the patient was slightly tachycardic at times but never exceeded 112bpm and also stated the alarm had occurred a few times in the last couple of hours.Getinge customer support (gcr) suggested swapping out to another console and tagging this unit to be tested by biomedical engineering.The nurse stated he had another cs300 readily available, and the gcr reviewed transitioning to another unit to reduce downtime of therapy.The nurse verbalized his confidence in doing so and verbalized that there was no harm to the patient because of this issue.
 
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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 Key10387334
MDR Text Key202361719
Report Number2249723-2020-01241
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,health
Type of Report Initial,Followup,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
Patient Weight82
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