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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 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date. Three (3) good faith efforts (gfes) to obtain the relevant repair and iabp status related to this complaint issue were made to the customer. However, despite our best efforts, the customer has not responded to any of our gfes. If additional information is provided, we will submit a supplemental report.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) generated a "low vacuum" alarm prior to discontinuation of therapy and removal of the intra-aortic balloon (iab). It was noted that the patient was in a paced rhythm of 80bpm at the time of the alarm and there was no interruption in patient therapy due to the alarm. There was no patient harm and no adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) generated a "low vacuum" alarm prior to discontinuation of therapy and removal of the intra-aortic balloon (iab). It was noted that the patient was in a paced rhythm of 80bpm at the time of the alarm and there was no interruption in patient therapy due to the alarm. There was no patient harm and no adverse event was reported.
 
Manufacturer Narrative
The customer's biomed has advised that they would be working along with getinge technical support to correct the issue themselves. The customer's biomed later reported that the issue has been resolved.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8721690
MDR Text Key151329953
Report Number2249723-2019-00989
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
Report Date 07/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Is This a Reprocessed and Reused Single-Use Device? No

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