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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53 - CARDIOSAVE HYBRID DOMESTIC
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information is being requested with regard to the repair and status of the iabp. A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed a gas loss alarm. The customer reported the iab was an axillary insertion and noted a chest x-ray revealed good placement. The customer placed the getinge representative on speakerphone so a dr. Who identified himself as (b)(6) could also interact. I reviewed the off-label use of the product and that i could continue to assist as from a femoral approach. The getinge representative reviewed checking for blood in the helium tubing and verifying that all connections secured on every occurrence of the alarm. Dr. (b)(6) stated the positional nature of the alarm. We also reviewed the option of lowering the augmentation bars by 1-2 in order to reduce the sensitivity of the alarm. They were both very thankful for the assistance. (b)(6) gave the necessary information for a complaint and biohazard return box to be sent. Pt is (b)(6) yo m 5¿8¿ (b)(6) lbs no patient harm, serious injury or adverse event was reported. Original balloon complaint (gas loss in iab circuit) reported in separate report mfg# 2248146-2021-00515.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, 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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12328492
MDR Text Key266889863
Report Number2249723-2021-01830
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,health
Reporter Occupation
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53 - CARDIOSAVE HYBRID DOMESTIC
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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