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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 N/A
Device Problem Accessory Incompatible (1004)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2021
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
 
Event Description
It was reported that the cardiosave battery charging station needs to be returned because is difficult for the customer to remove the battery pack from one of the slots.Since this is an accessory for the iabp, there was no patient involvement.
 
Manufacturer Narrative
Corrected fields: (health effect ¿ clinical code).
 
Event Description
It was reported that the cardiosave battery charging station needs to be returned because is difficult for the customer to remove the battery pack from one of the slots.Since this is an accessory for the iabp, there was no patient involvement.
 
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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 07430
MDR Report Key11381772
MDR Text Key233748021
Report Number2249723-2021-00426
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567111964
UDI-Public10607567111964
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,foreig
Type of Report Initial,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0802
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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