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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3013-XX
Device Problems Incorrect Or Inadequate Test Results (2456); Low Readings (2460); Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 01/17/2017
Event Type  Death  
Event Description
Customer reported that the systolic and diastolic blood pressure shown in the iabp monitor is less compared to the bed side monitor. Further, it was reported the bp was measured (via the radial artery) and monitored on the bedside monitor the customer is alleging the iabp malfunctioned and is attributing the malfunction to the patient's death.
 
Manufacturer Narrative
The production device history record (dhr) for the iabp involved in the event was reviewed. There were no non-conformances in the dhr related to the reported event.
 
Event Description
Customer reported that the systolic and diastolic blood pressure shown in the iabp monitor is less compared to the bed side monitor. Further, it was reported the bp was measured (via the radial artery) and monitored on the bedside monitor the customer is alleging the iabp malfunctioned and is attributing the malfunction to the patient's death.
 
Manufacturer Narrative
Additional information: furthermore, the company representative explained the reason for the difference in pressures between the iabp (intra-aortic balloon pump) monitor and the bedside monitor. The information conveyed that the iabp was working well. Additional tests were also conducted to check the consistency of pressure displayed in the iabp system and they were found to be correct. The company representative conducted an in service program to the hospital departments as a proactive measure. During follow up communication between the company representative and the customer, the customer reported that the patients' death was not attributed to the device. Furthermore, the company representative explained that the reason for the difference in pressures between the iabp (intra-aortic balloon pump) and the bedside monitor conveyed that the iabp was working well.
 
Event Description
Customer reported that the systolic and diastolic blood pressure shown in the iabp monitor is less compared to the bed side monitor. Further, it was reported the bp was measured (via the radial artery) and monitored on the bedside monitor the customer is alleging the iabp malfunctioned and is attributing the malfunction to the patient's death.
 
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Brand NameCS100
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key6287034
MDR Text Key104321347
Report Number2249723-2017-00003
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-3013-XX
Other Device ID NumberSA178604G0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/30/2017 Patient Sequence Number: 1
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