• 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 DOMESTIC 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 DOMESTIC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A getinge field service engineer (fse) evaluated the iabp and found the an expired 9v battery was expired and replaced it. Unrelated to the reported issue, the executive processor pcb was removed, the fiber optic connector was damaged, the p-clip that secures the coiled cable was broken, and the ion batteries were expired. The fse replaced them all. Full calibration was performed and the unit passed all functional and safety tests per factory specifications. The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a critical alarm for an expired 9v battery. This was discovered during a previously scheduled repair. There was no patient involvement, and no adverse event reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARDIOSAVE HYBRID DOMESTIC
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 Key11077487
MDR Text Key225340696
Report Number2249723-2020-02240
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2020
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-