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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 Problems Failure to Sense (1559); Protective Measures Problem (3015)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.(b)(6).
 
Event Description
It was reported that a sensation plus 50cc iab was inserted in a patient and as soon as the fiber optic cord was plugged into the cs300 intra-aortic balloon pump (iabp) the optical sensor failure alarm went off.The customer reported that in an attempt to correct the issue, the fiber optic cord was unplugged and re-plugged without success.The iabp was swapped to continue therapy, and the nonfunctioning iabp was taken out of service and the facility's biomed was notified of the issue.There was no patient harm and no adverse event was reported.
 
Event Description
It was reported that a sensation plus 50cc iab was inserted in a patient and as soon as the fiber optic cord was plugged into the cs300 intra-aortic balloon pump (iabp) the optical sensor failure alarm went off.The customer reported that in an attempt to correct the issue, the fiber optic cord was unplugged and re-plugged without success.The iabp was swapped to continue therapy, and the nonfunctioning iabp was taken out of service and the facility's biomed was notified of the issue.There was no patient harm and no adverse event was reported.
 
Manufacturer Narrative
The facility biomed reported that he was unable to reproduce the reported issue.The biomed performed a leak test and function test.The iabp was cleared for clinical use.
 
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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 Key8461347
MDR Text Key140953844
Report Number2249723-2019-00490
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 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
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
Device Age YR
Date Manufacturer Received05/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age63 YR
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