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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
Production device history record (dhr) review is not required as there was no malfunction of the cardiosave intra-aortic balloon pump; complaint event is due to an out-of-box failure of a getinge-manufactured part. The event site's full name was abbreviated as the name exceeded maximum character limit. The complete name is, "(b)(6). " additional information has been requested. A supplemental report will be sent upon receipt.
 
Event Description
It was reported that a new cardiosave intra-aortic balloon pump's (iabp) retractable power cord was received with damages. The power cord assembly could not be used due to these damages and has been deemed an out-of-box failure. This component requires replacement. There was no patient involvement or adverse event reported.
 
Manufacturer Narrative
The failed out of box part was returned to our national repair center for evaluation and inspection of the reel, ac power cord type b plug was completed with visual damage observed. The ac cord reel bracket fab was bent at the pem installed near the ac plug. Based on the visual inspection, the reel, ac power cord type b plug failed testing.
 
Event Description
It was reported that a new cardiosave intra-aortic balloon pump's (iabp) retractable power cord was received with damages. The power cord assembly could not be used due to these damages and has been deemed an out-of-box failure. This component requires replacement. There was no patient involvement or adverse event reported.
 
Manufacturer Narrative
The company representative has advised that the power cord was replaced in substitution of the power cord that failed out of box.
 
Event Description
It was reported that a new cardiosave intra-aortic balloon pump's (iabp) retractable power cord was received with damages. The power cord assembly could not be used due to these damages and has been deemed an out-of-box failure. This component requires replacement. There was no patient involvement or adverse event reported.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7583515
MDR Text Key110752901
Report Number2249723-2018-00979
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-XX
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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