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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 12/03/2018
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 supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported by a getinge company representative that upon powering up his personal demo cardiosave intra-aortic balloon pump (iabp), it emitted a continuous high pitched squeal and display power-up fault code #10. In addition, the helium transducer was not calibrated. This event occurred at his home office, thus there was no patient involvement or adverse event reported.
 
Event Description
It was reported by a getinge company representative that upon powering up his personal demo cardiosave intra-aortic balloon pump (iabp), it emitted a continuous high pitched squeal and displayed "power-up fault code #10. " in addition, the helium transducer was not calibrated. This event occurred at the getinge representative's home office, thus there was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
The suspected faulty executive power management board was returned to getinge¿s national repair center (ncr) for evaluation. A senior technician installed the executive power management board into the cardiosave test fixture and it tested to factory specifications per cardiosave service manual. The nrc could not verify the failure of the iabp not switching from dc to ac, after extensive runtime and complete charging of two cardiosave batteries. The board passed testing. The senior repair technician sent the part to supplier for failure analysis as per procedure. The suspected faulty executive processor board was returned to getinge¿s national repair center (ncr) for evaluation. A senior technician installed the executive processor board into the cardiosave test fixture and it tested to factory specifications per cardiosave service manual. The nrc could not verify the failure of power up code 10. The board passed testing. The senior repair technician sent the part to supplier for failure analysis as per procedure. The suspected faulty front end board was returned to getinge¿s national repair center (ncr) for evaluation. A senior technician installed the front end board into the cardiosave test fixture and it tested to factory specifications per cardiosave service manual. The nrc verified the failure of audible alarm, power up code 10. The ncr calibrated the transducers, however code 10 continued on power up. The board failed testing. The senior repair technician sent the part to supplier for failure analysis as per procedure. The ncr received the front end board from the supplier. The supplier verified the failure and installed cn70386 which rectified the failure code 10. The board passed testing. The ncr installed the board into the cardiosave test fixture and tested the board to factory specifications and cardiosave service manual. The board passed testing. The board will be packaged and labeled and sent to stock.
 
Manufacturer Narrative
A getinge service territory manager (stm) evaluated the iabp and was able to reproduce the reported issue. The stm powered up the iabp in service mode in an attempt to retrieve fault logs but was unable to, as all logs revealed illegible mixed characters. To resolve the issue, the stm replaced the executive processor board and attempted to complete calibrations and found that the iabp was not calibrating. The stm then replaced the front end board and was able to complete calibrations per section 4 of service manual. The stm also noticed that while completing calibrations, the iabp would not switch from d/c to a/c power. To resolve this issue, the stm replaced the power management board and confirmed that the batteries were charging. Unrelated to the complaint event, the iabp also had a helium leak at rg1; the stm followed the helium leak troubleshooting service bulletin and repaired the leak. In addition, the coiled cable and panel access knob were also replaced due to damage. Full preventative maintenance (pm), calibration, safety and functionality checks were completed per the service manual and passed per factory specifications. The iabp was returned to the customer and cleared for clinical use.
 
Event Description
It was reported by a getinge company representative that upon powering up his personal demo cardiosave intra-aortic balloon pump (iabp), it emitted a continuous high pitched squeal and displayed "power-up fault code #10. " in addition, the helium transducer was not calibrated. This event occurred at the getinge representative's home office, thus there was no patient involvement and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8196993
MDR Text Key131590345
Report Number2249723-2018-02218
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
Type of Report Initial,Followup,Followup,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Is This a Reprocessed and Reused Single-Use Device? No

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