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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 N/A
Device Problem Failure to Sense (1559)
Patient Problems Arrhythmia (1721); No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to evaluate the iabp and was unable to duplicate the reported issue.The facility biomedical engineer stated that the patients heart beat was irregular.Also customer state that a size 40 maquet balloon was used on a patient of substantial size and it may have been a bit undersized, and it was placed a little low once viewed under x-ray.The stm performed all functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.(b)(6).
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) was inflating twice for each trigger.It is unknown if there was any patient harm/injury; however there was no adverse event reported.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) was inflating twice for each trigger.It was later reported by the facility's biomed technician that the patient's heart beat was irregular, and that a size 40 maquet intra-aortic balloon catheter (iabc) was used on a patient of substantial size and it may have been a bit undersized, and placed a little low once viewed under x-ray.It is unknown if the customer attributes the patient injury to the unit.Please refer to mfg report number 2248146-2020-00044 for information on the iabc.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.Additional information will be submitted if available.Update fields: b4, g4, g7, h10, h11.Corrected field: b1, b2, b5, d11, g1, h1, h2, h4, h6 (evaluation method codes, patient code and evaluation conclusion codes).
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) was inflating twice for each trigger.It was later reported by the facility's biomed technician that the patient's heart beat was irregular, and that a size 40 maquet intra-aortic balloon catheter (iabc) was used on a patient of substantial size and it may have been a bit undersized, and placed a little low once viewed under x-ray.It is unknown if the customer attributes the patient injury to the unit.Please refer to mfg report number 2248146-2020-00044 for information on the iabc.
 
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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 Key9607022
MDR Text Key191719450
Report Number2249723-2020-00099
Device Sequence Number1
Product Code DSP
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,user f
Type of Report Initial,Followup,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
40 MAQUET IABC / MODEL UNKNOWN; 40 MAQUET IABC / MODEL UNKNOWN
Patient Outcome(s) Other;
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