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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problems Device Alarm System (1012); Communication or Transmission Problem (2896); Device Sensing Problem (2917)
Patient Problem Death (1802)
Event Date 05/04/2015
Event Type  Death  
Manufacturer Narrative
(b)(4).The company representative was unable to duplicate the reported problem and unable to find any "autofill failure" alarms in the logs.The iabp was tested to factory specification.It functioned normally and was returned to the customer.(b)(4).The company representative was unable to duplicate the reported problem and to find any "autofill failure" alarms in the logs.The iabp was tested to factory specification.It functioned normally and was returned to the customer.The customer informed the service representative that they believe the unit was working properly but they wanted a maquet representative to ensure proper functionality of iabp.
 
Event Description
The customer reported that while trying to perform therapy with unit, they had poor ecg signal and occasional no trigger alarms.Customer was unsure if there were any autofill alarms.The patient died.The customer also stated that ecg signal would come and go and sometimes was very weak while clinicians were performing cpr on patient.They were trying to revive patient for 1 hour and 45 minutes on cath lab table.Every compression the clinical staff administered they would see the compression on the display of the unit.The customer informed the service representative that they believe the unit was working properly but they wanted a maquet representative to ensure proper functionality of iabp.
 
Manufacturer Narrative
02/24/2016 07:26 pm (gmt-5:00) added by (b)(4): the manufacturer attempted multiple times to obtain additional information referent to the circumstances of the event however no response was received from the customer.
 
Event Description
The customer reported that while trying to perform therapy with unit, they had poor ecg signal and occasional no trigger alarms.Customer was unsure if there were any autofill alarms.The patient died.The customer also stated that ecg signal would come and go and sometimes was very weak while clinicians were performing cpr on patient.They were trying to revive patient for 1 hour and 45 minutes on cath lab table.Every compression the clinical staff administered they would see the compression on the display of the unit.The customer informed the service representative that they believe the unit was working properly but they wanted a maquet representative to ensure proper functionality of iabp.
 
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Brand Name
CS300
Type of Device
SYSTEM, 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 Key5406063
MDR Text Key37333338
Report Number2249723-2016-00001
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received02/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age71 YR
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