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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Event Description
It was reported that during preventive maintenance (pm) that the cs300 intra-aortic balloon pump (iabp) displayed an electrical error #52.Customer brought machine to field service engineer fse, who turned it on, and then machine went into a system alarm and displayed an electrical error 52.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
Testing of actual/suspected device (10,3213) a getinge field service engineer (fse) evaluated the iabp during a routine pm.Customer brought machine to fse, who turned it on, and then machine went into a system alarm and displayed an electrical error 52.Fse found the machine quenched in saline, the front board was damaged.Fse replaced the front end pcb, (0670-00-0668), which corrected the issue.Full calibration, functional, and safety checks were performed which passed to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted if this information is provided to us.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).
 
Event Description
It was reported that during preventive maintenance (pm) that the cs300 intra-aortic balloon pump (iabp) displayed an electrical error #52.Customer brought machine to field service engineer fse, who turned it on, and then machine went into a system alarm and displayed an electrical error 52.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period oct 2019 through sep 2021 was reviewed.There were no triggers identified for the review period.
 
Event Description
N/a.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12555518
MDR Text Key274154265
Report Number2249723-2021-02203
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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