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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYP B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYP B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/04/2021
Event Type  Injury  
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump was turned off due to a possibility that there was something wrong with the intra-aortic balloon (iab) catheter. The bedside nurse reported that the iab catheter was still in place, not pumping. The patient was bleeding elsewhere and has been determined to be ¿comfort care¿. The plan was to take the patient to surgery to remove the iab, but since the patient had been deteriorating and made a dnr, they are not taking the patient to surgery. The iab was asked to be returned to the manufacturer. The iab was reported under mfg report number 2248146-2021-00701 ((b)(4)).
 
Manufacturer Narrative
The iabp did not experience a malfunction during patient therapy, it was turned off. The iabp did what it was supposed to, and was not taken out from clinical use due to a malfunction. In addition the customer has not requested getinge service. A supplemental report will be submitted upon completion of our investigation. (b)(6). Not returned to manufacturer.
 
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Brand NameCARDIOSAVE HYBRID TYP B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
MDR Report Key12706308
MDR Text Key281843965
Report Number2249723-2021-02473
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
Treatment
UNKNOWN INTRA-AORTIC BALLOON CATHETER
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