Model Number 0998-00-3023-53 |
Device Problems
Device Alarm System (1012); Communication or Transmission Problem (2896); Device Sensing Problem (2917)
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Patient Problem
Death (1802)
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Event Date 05/04/2015 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).The company representative was unable to duplicate the reported problem and unable to find any "autofill failure" alarms in the logs.The iabp was tested to factory specification.It functioned normally and was returned to the customer.(b)(4).The company representative was unable to duplicate the reported problem and to find any "autofill failure" alarms in the logs.The iabp was tested to factory specification.It functioned normally and was returned to the customer.The customer informed the service representative that they believe the unit was working properly but they wanted a maquet representative to ensure proper functionality of iabp.
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Event Description
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The customer reported that while trying to perform therapy with unit, they had poor ecg signal and occasional no trigger alarms.Customer was unsure if there were any autofill alarms.The patient died.The customer also stated that ecg signal would come and go and sometimes was very weak while clinicians were performing cpr on patient.They were trying to revive patient for 1 hour and 45 minutes on cath lab table.Every compression the clinical staff administered they would see the compression on the display of the unit.The customer informed the service representative that they believe the unit was working properly but they wanted a maquet representative to ensure proper functionality of iabp.
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Manufacturer Narrative
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02/24/2016 07:26 pm (gmt-5:00) added by (b)(4): the manufacturer attempted multiple times to obtain additional information referent to the circumstances of the event however no response was received from the customer.
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Event Description
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The customer reported that while trying to perform therapy with unit, they had poor ecg signal and occasional no trigger alarms.Customer was unsure if there were any autofill alarms.The patient died.The customer also stated that ecg signal would come and go and sometimes was very weak while clinicians were performing cpr on patient.They were trying to revive patient for 1 hour and 45 minutes on cath lab table.Every compression the clinical staff administered they would see the compression on the display of the unit.The customer informed the service representative that they believe the unit was working properly but they wanted a maquet representative to ensure proper functionality of iabp.
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Search Alerts/Recalls
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