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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/30/2020
Event Type  Death  
Manufacturer Narrative
Additional initial reporter name - (b)(6). Additional email address - (b)(6). The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint record id # (b)(4).
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) shutdown in the middle of the therapy. In addition customer reported that no alarms were heard and no abnormal operation was detected. The customer then turned the power switch off and back on and the unit was able to turned on, the patient therapy was discontinued and patient was transitioned to another cs300 iabp. There was no reported malfunction on the intra-aortic balloon(iab). A separate report will be submitted for the cs300 intra-aortic balloon pump (iabp).
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Failure modes are addressed in the risk file. The ifu cannot be reviewed as there was no reported malfunction. There were no ncmrs identified. The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit. The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months). Based on the rational provided above, no escalation to the capa process is required. Reference complaint #: (b)(4).
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) shutdown in the middle of the therapy. In addition customer reported that no alarms were heard and no abnormal operation was detected. The customer then turned the power switch off and back on and the unit was able to turned on, the patient therapy was discontinued and patient was transitioned to another cs300 iabp. There was no reported malfunction on the intra-aortic balloon(iab). A separate report will be submitted for the cs300 intra-aortic balloon pump (iabp).
 
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Brand NameUNKNOWN IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key10945264
MDR Text Key219483834
Report Number2248146-2020-00642
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/04/2020 Patient Sequence Number: 1
Treatment
CS300
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