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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 Problems Device Alarm System (1012); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2017
Event Type  malfunction  
Manufacturer Narrative
The facility¿s biomedical engineer (biomed) has advised that it was later discovered that the batteries were the reason for the alleged malfunction of the intra-aortic balloon pump (iabp), and it was not an autofill problem. It was also reported by the biomed that the batteries were replaced which resolved the issue, and that the iabp has been returned to clinical service with no other reported issues.
 
Event Description
Customer reported that a call was received from rn/icu reporting auto fill failure on the cardiosave intra-aortic balloon pump (iabp) and they were unable to initiate the therapy. The nurse verified all the connections were tight and no blood was detected in the extender tubing. Customer had another pump on hand so company representative requested the nurse to switch the pumps while they were on phone. There was no alarm on the new pump, and pumping was initiated. The company representative then requested the nurse to pull the previous pump out of the service for biomed/ getinge maquet service to look into the issue further. No adverse event was reported.
 
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. If additional repair information is provided by the customer, we will provide accordingly. Should have read amanda drinkwater, but only the first name was inserted due to the contents exceeding maximum characters.
 
Event Description
Customer reported that a call was received from rn/icu reporting auto fill failure on the cardiosave intra-aortic balloon pump (iabp) and they were unable to initiate the therapy. The nurse verified all the connections were tight and no blood was detected in the extender tubing. Customer had another pump on hand so company representative requested the nurse to switch the pumps while they were on phone. There was no alarm on the new pump, and pumping was initiated. The company representative then requested the nurse to pull the previous pump out of the service for biomed/ getinge maquet service to look into the issue further. No 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 Key6816835
MDR Text Key104057681
Report Number2249723-2017-00332
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 10/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2017
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?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/10/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2012
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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