Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 12/17/2018
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 company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge stm has advised that the iabp is pending repairs because the part is on backorder.A supplemental report will be submitted when additional information is provided.The initial reporter named is a getinge employee who has different contact details from that of the event site.Please refer to the following email: (b)(6).
 
Event Description
It was reported by a getinge service territory manager (stm) that upon uncrating the cardiosave intra-aortic balloon pump (iabp) from the maquet repair depot, the helium tank drawer would not slide out so that the tank could be installed.No patient involvement or adverse event was reported.
 
Event Description
It was reported by a getinge service territory manager (stm) that upon uncrating the cardiosave intra-aortic balloon pump (iabp) from the maquet repair depot, the helium tank drawer would not slide out so that the tank could be installed.No patient involvement or adverse event was reported.***an initial emdr for this complaint was incorrectly submitted.This is a non-reportable complaint with a severity category of "minor", which is non-reportable to the fda.As a result, no follow up emdr is necessary, as the severity category has been changed to "minor", in our database.Please cancel in your database.
 
Manufacturer Narrative
An initial emdr for this complaint was incorrectly submitted.This is a non-reportable complaint with a severity category of "minor", which is non-reportable to the fda.As a result, no follow up emdr is necessary, as the severity category has been changed to "minor", in our database.Please cancel in your database.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8233244
MDR Text Key133860551
Report Number2249723-2019-00057
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
Type of Report Initial,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-