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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-55
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2020
Event Type  malfunction  
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge service technician (st) blood inside the pneumatic module assembly was observed.There was no patient involvement.
 
Manufacturer Narrative
The getinge service technician (st) replaced the pneumatic module assembly (0997-00-1178)during the preventative maintenance (pm) and performed functional and safety checks.The iabp was returned to the customer and cleared for clinical use.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).
 
Event Description
N/a.
 
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Brand Name
CARDIOSAVE HYBRID W/ E/F PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key16068885
MDR Text Key308491974
Report Number2249723-2022-03469
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-55
Device Catalogue Number0998-00-0800-55
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/14/2020
Initial Date FDA Received12/29/2022
Supplement Dates Manufacturer Received01/24/2023
Supplement Dates FDA Received01/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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