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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
Catalog Number 0998-00-0800-53
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to evaluate the iabp unit. The customer broke the fiber-optic connector. The stm replaced the fiber-optic connector assembly. The stm completed all safety, functionality and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer.
 
Event Description
It was reported that during transport of a patient, the cardiosave intra-aortic balloon pump (iabp) had a broken fiber-optic connection. After moving the patient to the receiving hospital and taking the patient out of the ambulance, the iabp cables were plugged back into the iabp and no pressure diagnostics were showing. The iabp was still augmenting and the ekg wave was fine. No patient harm, serious injury or 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 Key10601079
MDR Text Key209011072
Report Number2249723-2020-01582
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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,user f
Reporter Occupation
Type of Report Initial
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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