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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp and determined that the system was recognizing the ac power and batteries, but it was not charging the batteries. The event logs revealed a critical fault code "power management board communication error - fault code # 139" logged several times; in which this communication error between the power management board, backplane board, and executive processor board was causing a fault or interruption in the battery charging circuit. The power management board was removed and replaced, and all cable connections between the backplane board and the executive processor board were resecured. Also, both battery bays, compressor & chassis fans were vacuumed and cleaned with compressed air and an anti-static brush. Once console was reassembled and reinserted to the hospital cart, the system passed all battery operational checks. The battery charging circuit was functioning correctly, and the battery run time passed. The fse verified the console battery label indicator and the hospital cart charging label indicator and both functioned properly. He then performed all functional and safety checks to meet factory specifications. Unit passed all functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) had batteries that were not charging, the iabp was swapped out. No patient harm, serious injury or adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11957341
MDR Text Key254866024
Report Number2249723-2021-01210
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/08/2021 Patient Sequence Number: 1
Treatment
UNKNOWN.
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