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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
Catalog Number 0998-00-0800-53
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2018
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date. Getinge service has not been requested at this time. Additional information has been requested, and we will report accordingly if it becomes available.
 
Event Description
It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) had an abnormal waveform resulting in abnormal readings. Nothing had changed with the patient, all connections were checked. The iabp had been running for approximately 48 hours. The customer weaned the patient and disconnected the iabp. It was also reported that the iabp had strange waveforms sometime in the fall. It was advised that no blood was seen in the tube set. No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
The customer reported that the alleged malfunction was a result of a setting error. The iabp has since been used without issue.
 
Event Description
It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) had an abnormal waveform resulting in abnormal readings. Nothing had changed with the patient, all connections were checked. The iabp had been running for approximately 48 hours. The customer weaned the patient and disconnected the iabp. It was also reported that the iabp had strange waveforms sometime in the fall. It was advised that no blood was seen in the tube set. No patient harm, serious injury or adverse event was reported.
 
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Brand NameCARDIOSAVE
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 Key7288561
MDR Text Key100917368
Report Number2249723-2018-00278
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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