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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-53
Device Problem Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/20/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge service territory manager (stm) evaluated the iabp and was only able to recreate the reported complaint one time. It was determined that this was due to a faulty ecg trunk cable. However, the faulty cable was discarded. The stm fully tested the unit, and the iabp passed all functional and safety tests. The iabp was returned to the customer and cleared for clinical use. In addition, the stm found that one of the customer's ecg cables was found to have wet cleaning solution inside the ecg trunk cable to the lead wire connector. The customer was advised to alter their cleaning procedure as this could be a possible cause of the issue. The hospital biomed dept. Will continue to monitor the situation and report any additional issues.
 
Event Description
It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) had an ecg monitor issue. The customer was unable to acquire an ecg signal on their iabp unit. When the patient was disconnected from a transport monitor in the or and connected to the iabp, there was no ecg signal displayed on the iabp. The customer switched ecg cables and ecg electrodes several times without correcting the issue. No adverse event was reported.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7739327
MDR Text Key115780185
Report Number2249723-2018-01289
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 08/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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