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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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
Communication/interviews: the customer performed initial troubleshooting over the phone and was unable to power up the unit even while plugged in and verified that the batteries were properly seated in the battery bays.It was discussed on how to make sure that the console was appropriately engaged in the hospital cart.At this time, the customer has not requested for getinge to evaluate the cardiosave intra-aortic balloon pump (iabp) unit involved in this event.A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use the cardiosave intra-aortic balloon pump (iabp) unit would not charge.The customer switched out the iabp unit for another iabp unit to continue therapy without issue.It was recommended that the unit be tagged for biomed to evaluate.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
After further investigation, it was identified that this complaint event has been reported already under mfg report number 2249723-2022-00689.Please refer to mfg report number 2249723-2022-00689 for all information for this complaint event.Please cancel this mfg report number in your database.Revert all sections to blank : b.Adverse event or product problem.D.Suspect medical device.E.Initial reporter.G.All manufacturers.H.Device manufacturers only.
 
Event Description
After further investigation, it was identified that this complaint event has been reported already under mfg report number 2249723-2022-00689.Please refer to mfg report number 2249723-2022-00689 for all information for this complaint event.Please cancel this mfg report number in your database.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key13942760
MDR Text Key290453369
Report Number2249723-2022-00673
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/12/2024
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 Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/02/2022
Initial Date FDA Received03/29/2022
Supplement Dates Manufacturer Received01/08/2024
Supplement Dates FDA Received01/12/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
INTRA-AORTIC BALLOON.
Patient Age63 YR
Patient SexMale
Patient Weight59 KG
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