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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-XX
Device Problems Air Leak (1008); Device Alarm System (1012); Loss of Power (1475)
Patient Problem Death (1802)
Event Date 07/08/2016
Event Type  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. The iabp is currently under investigation by the company representative but the evaluation results are not available yet.
 
Event Description
The customer reported that immediately after therapy started some sounds were heard, and the pump was losing air. Twice, the iabp stopped working for 30 seconds, but no alarm was generated. Therapy resumed for 6 hours on the same iabp with no adverse event reported. This occurred in the evening, but the patient passed away the following morning. There is no device relationship directly with the patient death. As per hospital policy, no patient information is provided.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key5861405
MDR Text Key51688576
Report Number2249723-2016-00024
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 07/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number0998-00-0800-XX
Device Catalogue Number0998-00-0800-XX
Other Device ID NumberCA233537H3
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 Received07/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2013
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/09/2016 Patient Sequence Number: 1
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