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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during preventive maintenance performed at 5000 hours (pm) by a getinge service territory manager (stm) , the cs100 intra-aortic balloon pump (iabp) units safety disk was replaced.There was no patient involvement reported.
 
Manufacturer Narrative
Complaint is being cancelled as it was opened in error.Revert all sections to blank : b.Adverse event or product problem d.Suspect medical device e.Initial reporter g.All manufacturers h.Device manufacturers only.
 
Event Description
Complaint is being cancelled as it was opened in error.
 
Manufacturer Narrative
No malfunction occurred with the unit.
 
Event Description
Retraction mdr.Revert to blank.Based on information provided that no malfunction occurred with the unit.
 
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Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key17191957
MDR Text Key317768413
Report Number2249723-2023-02913
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 09/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Date Manufacturer Received09/25/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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