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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300, ENGLISH,NON-UTS,DOM SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300, ENGLISH,NON-UTS,DOM SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-53
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2021
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted if additional information is provided. The full name of the event site was shortened due to field character limit; the full name is (b)(6). Customer did not request service.
 
Event Description
It was reported by the customer during use, that there was no ecg waveform in the cs300 intra-aortic balloon pump (iabp) while in auto/pressure trigger. The customer informed us that the ecg pads were replaced and all ecg trunk cable connections and lead were checked. Getinge help support advised that they should consider trying another cable but customer reported that no pump or cable were available, they were locked in the cath lab at that time. Subsequently, a facetime call showed a sporadic ecg and scrolling through leads 1,2,and 3. The customer did not have an external access. Attempted scrolling through leads in semi auto and there was a consistent waveform in the avr, avl leads. Help support advised now to place in ecg trigger, but will need to time the pump. Since the customer was not familiar with this, an attempt was made to assist with timing but there was an understanding and a language barrier. Finally, another attempt at auto was made and consistent ecg was present, now in lead 1. The help support advised again that they should consider another cable and/or pump to rule out a problem with either. They will report this pump to their biomed department once available. No patient harm, serious injury or adverse event was reported.
 
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Brand NameCS300, ENGLISH,NON-UTS,DOM
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 Key12246395
MDR Text Key264107921
Report Number2249723-2021-01630
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 company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3013-53
Device Catalogue Number0998-00-3013-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse
Removal/Correction NumberN/A

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