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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Inability to Auto-Fill (1044); Mechanical Problem (1384); Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem No Patient Involvement (2645)
Event Date 08/29/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit was reviewed and no non-conformances related to the reported event were noted. A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit, replaced the helium fill assembly and the fault disappeared. The iabp unit was tested according to protocol and free of defects. The unit was returned to the customer and cleared for clinical use. The initial reporter named is a getinge employee who has different contact details from that of the event site. Please refer to the following email and phone number as contact information for the initial reporter: (b)(6).
 
Event Description
It was reported that during the first 1st clinical training of the cardiosave intra-aortic balloon pump (iabp), the unit did not autofill. By manual activation, it seemed k3 opened and 11 did not open properly because vacuum did not reach the balloon. The sound of k3 was ok; however, k11 made a very low click noise. There was no patient involvement; thus no adverse event was reported.
 
Manufacturer Narrative
The faulty helium fill manifold assembly was returned to the getinge national repair center (nrc) for further investigation. A technician of the nrc performed visual inspections of the helium fill manifold assembly and no findings were observed. The technician installed the helium fill manifold assembly into a cardiosave test fixture. The test fixture was powered up into system diagnostics mode. No displayed failure messages were observed. All manifold tests were performed and successfully passed all tests. Autofill tests were performed and failed the flush fill test only. There was an internal failure of the defective helium fill manifold assembly.
 
Event Description
It was reported that during the first 1st clinical training of the cardiosave intra-aortic balloon pump (iabp), the unit did not autofill. By manual activation, it seemed k3 opened and 11 did not open properly because vacuum did not reach the balloon. The sound of k3 was ok; however, k11 made a very low click noise. There was no patient involvement; thus no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE E/F PLG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key7903850
MDR Text Key121708303
Report Number2249723-2018-01649
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 01/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-55
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 Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No

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