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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Display or Visual Feedback Problem (1184); No Audible Prompt/Feedback (2282); Defective Device (2588); Battery Problem (2885)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. The fse that discovered the issue has advised that the alarm daughter board has been ordered and will be replaced in the iabp. A supplemental report will be submitted when additional information is made available. The full event site address in the 1st address field is (b)(6).
 
Event Description
It was reported that during preventative maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) would not generate a beep sound after pushing the test button on the alarm daughter board. It was noted that the 9v battery was replaced and still no alarm was heard. The fse suspected that the alarm daughter board was defective. There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
Upon further evaluation by the getinge field service engineer (fse) it was found that the battery which was taken from the doppler to troubleshoot the issue does not work with the alarm daughter board. The fse installed a new 9v battery (as part of the preventative maintenance protocol) and the alarm daughter board worked with beep sound when the test button was pushed. The fse completed all safety, functionality, and calibration checks and all tests passed per factory specifications. The iabp unit was returned to the customer and cleared for clinical use.
 
Event Description
It was reported that during preventative maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) would not generate a beep sound after pushing the test button on the alarm daughter board. It was noted that the 9v battery was replaced and still no alarm was heard. The fse suspected that the alarm daughter board was defective. There was no patient involvement and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8272609
MDR Text Key134081926
Report Number2249723-2019-00120
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,foreig
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received04/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

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