• 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. CARDIOSAVE HYBRID TYPE I (AU); 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. CARDIOSAVE HYBRID TYPE I (AU); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-31
Device Problems Premature Discharge of Battery (1057); Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
Event Description
It was reported during normal check of the cardiosave intra-aortic balloon pump (iabp) failing battery test and faulty power cord retractor.There was no patient involvement reported.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
Event site postal code: (b)(6).A getinge field safety engineer (fse) was dispatched to evaluate the unit.The fse replaced the li-ion battery pack and reel, ac power cord to resolve the issue.The failure analysis and testing dept.Received part with a reported unit failure of a failed battery test and faulty power cord retractor.The fat performed a visual inspection and found the part to have a loose power cord and the reel not being able to retract.Tested continuity and one of the wires was faulty in the cord.Fat verified the reported failure but no root cause identified.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.
 
Event Description
N/a.
 
Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.
 
Event Description
N/a.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARDIOSAVE HYBRID TYPE I (AU)
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key18334832
MDR Text Key330599196
Report Number2249723-2023-05293
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567109053
UDI-Public(01)10607567109053(21)CB351297D2
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 09/25/2024
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 Health Professional
Device Model Number0998-00-0800-31
Device Catalogue Number0998-00-0800-31
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2023
Initial Date FDA Received12/15/2023
Supplement Dates Manufacturer Received05/14/2024
09/25/2024
Supplement Dates FDA Received05/15/2024
10/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2022
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-