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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-61
Device Problems Failure to Calibrate (2440); Pressure Problem (3012)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed that the iabp unit was not calibrated.The fse calibrated the iabp unit.A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had an anomaly in work pressure and was not calibrated.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
Event Description
It was reported that before use, the cs300 intra-aortic balloon pump (iabp) had an anomaly in work pressure, it was unbalanced not calibrated.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h4, h6 (type of investigation), h10.
 
Event Description
It was reported that before use, the cs300 intra-aortic balloon pump (iabp) had an anomaly in work pressure, it was unbalanced not calibrated.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Updated fields: a1, a3 (to be left blank) d4 (version or model#), e1 (initial reporter).The getinge field service engineer (fse) that had evaluated and calibrated the iabp reported that no parts were replaced, and that the iabp unit was returned to the customer and cleared for clinical use.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10924823
MDR Text Key221864031
Report Number2249723-2020-02038
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108278
UDI-Public10607567108278
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,foreig
Type of Report Initial,Followup,Followup
Report Date 05/25/2021
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 Number0998-00-3023-61
Device Catalogue Number0998-00-3023-61
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/06/2020
Initial Date FDA Received12/01/2020
Supplement Dates Manufacturer Received04/09/2021
05/25/2021
Supplement Dates FDA Received05/06/2021
06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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