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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-52
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to verify the alarm in the error logs.Unit passed all functional and safety test per factory specifications.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) gave catheter restriction alarm.Patient was stable and customer swapped to another unit.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to verify the alarm in the error logs.The fse inspected the iabp unit and performed a full calibration including functional checks but no fault was observed.Subsequently, the fse completed all functional and safety test per factory specifications and all testing passed.The iabp unit was then cleared for use and returned to the customer.
 
Event Description
N/a.
 
Manufacturer Narrative
Analysis of production: (3331/213) the device history records 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: (4109/213) 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: (4110/213) the overall 24 month product complaint trend data for the period jun-2019 through may-2021 was reviewed.There were no triggers identified for the review period.
 
Event Description
N/a.
 
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Brand Name
CARDIOSAVE HYBRID TYPE G 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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11966944
MDR Text Key259717196
Report Number2249723-2021-01225
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108438
UDI-Public10607567108438
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/15/2022
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 Number0998-00-0800-52
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2021
Initial Date FDA Received06/09/2021
Supplement Dates Manufacturer Received06/10/2021
04/15/2022
Supplement Dates FDA Received07/02/2021
05/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2019
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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