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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. A getinge service territory manager (stm) has advised that the customer has not requested for service of the iabp, but has been provided with a replacement power supply. The stm followed up with the customer to verify the receipt of the part, and the customer confirmed the part was received and the iabp unit had been returned to use.
 
Event Description
It was reported that during in-service training performed by a getinge therapy specialist, the cardiosave intra-aortic balloon pump (iabp) would not recognize the removable power supply when it was placed into battery bay#2 of the iabp unit in rescue configuration. However, the iabp unit would recognize the battery when it was placed back into the battery bay. In addition, when the iabp unit was placed back into the pump cart, the battery was recognized. It was noted that during the first in-service training, the power supply worked, but during the second in-service which was approximately two hours later, the power supply did not work. The customer is requesting replacement of the power supply. There was no patient involved and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key9239193
MDR Text Key190208214
Report Number2249723-2019-01713
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/13/2019
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/13/2019
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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