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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Event Description
As reported per medwatch (b)(4). Received on 08october 2021: at approximately 1600 hours, the iabp was checked by the nurse per protocol and identified to be in good working order and functioning appropriately with a 1:1 ratio. Around sometime between 1620 to 1640 hours, the balloon pump was noted to be in a 1:3 ration, which to date i cannot identify the circumstances related to that change. The iabp was placed in standby by the int cards fellow for a planned re-positioning that was unrelated to the previously mentioned change in augmentation ration. After the pump was in standby, the iabp was re-positioned, it was appropriately left in standby to await cxr confirmation of the positioning. During that time, the int cards fellow was interrupted for patient care issues unrelated to the patient described here. The iabp was unintentionally left in standby. When identified around 1700 hours, the pump was placed back into 1:3 ration. Shortly thereafter, it was turned to a 1:1 ratio given that the reason for being in a 1:3 ratio could not be identified by discussing with interdisciplinary teams and searching for others in the emr.
 
Manufacturer Narrative
No repair information has been provided at this time.
 
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Brand NameCS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
MDR Report Key12723800
MDR Text Key282964480
Report Number2249723-2021-02507
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device?

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