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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-83
Device Problems Inability to Auto-Fill (1044); Noise, Audible (3273)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to the customer's site. The stm observed severe damage to rear of console above rear handle. The stm removed console cover and observed pressure hose cut causing massive leak to pressure canister. This damage caused poor augmentation and gas restriction alarms when console covered was installed. The stm replaced console cover, rear latch handle and pressure hose. The stm replaced damaged parts due to customer negligence and corrected failure. The stm then performed all calibration, functional and safety tests on iabp, which passed. The iabp was returned to customer and cleared for clinical use. (b)(6).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had an autofill error. Additionally, it was reported that the iabp unit was making noise. It is unknown the circumstances under which the event occurred. It is also unknown if there was a patient involvement. However, there was no adverse event reported.
 
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Brand NameCARDIOSAVE RESCUE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11382653
MDR Text Key233752220
Report Number2249723-2021-00442
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K0112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-83
Device Catalogue Number0998-00-0800-83
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2014
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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