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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
Model Number 0998-00-0800-65
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2023
Event Type  malfunction  
Manufacturer Narrative
Due to character restrictions initial reporter address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit notified maintenance required.
 
Event Description
It was reported that , the cardiosave intra-aortic balloon pump (iabp) unit notified maintenance required.There was no patient involvement.
 
Manufacturer Narrative
Complaint record being cancelled as it is a duplicate to tw(b)(4).Mfg report number 2249723-2023-00228.Revert the following fields 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 record being cancelled as it is a duplicate to tw(b)(4).Mfg report number 2249723-2023-00228.
 
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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 Key16178656
MDR Text Key308465325
Report Number2249723-2023-00228
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/07/2023
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 Health Professional
Device Model Number0998-00-0800-65
Device Catalogue Number0998-00-0800-65
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/05/2023
Initial Date FDA Received01/16/2023
Supplement Dates Manufacturer Received01/17/2023
02/07/2023
Supplement Dates FDA Received02/06/2023
02/07/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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