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 CORP. - 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 CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The stm replaced the power management board and noted that the battery was charging and ac power resumed operation.Subsequently, the stm completed pm service including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) did not have a functional battery and ac power did not function.There was no patient involved and no adverse event was reported.
 
Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h10.The suspected defective power management board was requested to be returned to getinge's national repair center (nrc) for failure investigation.However, the field service engineer(fse) has advised that the part is not available for return as it was discarded in error.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) did not have a functional battery and ac power did not function.There was no patient involved and no adverse event was reported.
 
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 CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key9483029
MDR Text Key191465317
Report Number2249723-2019-02054
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 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/17/2019
Supplement Dates Manufacturer Received01/31/2020
Supplement Dates FDA Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-