• 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. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V 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. - 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 High Readings (2459)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/16/2022
Event Type  Death  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate. The fse performed a preliminary exam on the iabp unit to ensure it was working appropriately. The iabp unit was observed to work perfectly with no error codes or alarms logged in the system. As this is a rental unit, the iabp unit was not returned to the customer but would be transported back to the getinge warehouse where a full preventative maintenance (pm) and checkout would be performed at a later date. A supplemental report will be submitted upon completion of our investigation. An additional contact at the event site was provided and is as follows: (b)(6).
 
Event Description
It was reported that during use on a patient, the rental cs300 intra-aortic balloon pump (iabp) functioned ok; however, the patient expired due to illness. The customer later called back as additional information was received from staff and notes from the patient's chart. The customer reports that the details are not certain and that the nurse caring for the patient was very new with little balloon pump experience. The customer stated that while in use, it was noted that the augmentation suddenly doubled from the low 100's to the 200's. The customer also reported that a nurse practitioner at the bedside at the time noted that the a-line waveform did not match the indices on the iabp unit and there may have been a perception that something wasn't right with the iabp unit. The customer stated that the indices displayed the systolic pressure much higher than it actually was and the patient was switched from iv levophed to iv nitroglycerin to manage the blood pressure. At some pint during treatment, the patient went into cardiac arrest, coded, and expired in the sicu. The patient was post myocardial infarction (mi) in cardiogenic and septic shock. The customer indicated the patient was very sick at the time. There were no reported alarms or message on the iabp unit during this time. The iabp unit was sent to the customer's biomed. The customer has not attributed the patient's death to the device. Patient height: 182cm. The associated intra-aortic balloon (iab) involved in this event has been reported under medwatch 2248146-2022-00289.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key14140291
MDR Text Key289484905
Report Number2249723-2022-00886
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/19/2022 Patient Sequence Number: 1
Treatment
INTRA-AORTIC BALLOON.
-
-