Model Number 20 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/09/2014 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control evaluated the device and verified the reported failure.The cause of the reported failure was determined to be that the user interface flex cable assembly was not fully seated into the connector on the user interface pcb assembly.Once connected, normal functionality was observed.Physio then performed unrelated repairs and observed proper device operation through functional and performance testing.The device was then returned to the customer for use.
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Manufacturer Narrative
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The initial medwatch report indicates: physio-control evaluated the device and verified the reported failure.The cause of the reported failure was determined to be that the user interface flex cable assembly was not fully seated into the connector on the user interface pcb assembly.Once connected, normal functionality was observed.Physio then performed unrelated repairs and observed proper device operation through functional and performance testing.The device was then returned to the customer for use.The initial medwatch report should indicate: physio-control evaluated the device and verified the reported failure.Physio replaced the system controller and user interface pcb assemblies.It was also observed that the user interface flex cable assembly was not fully seated into the connector on the user interface pcb assembly.After the pcbs were replaced and the flex cable assembly was attached properly, normal operation was observed through functional and performance testing and the device was returned to the customer for use.Physio further evaluated the removed pcb assemblies and determined that the cause of the reported failure was due to a failure of an integrated circuit chip, designator u61 from the system controller pcb assembly.
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Event Description
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The customer reported that the device was locking up during the self test.Once the device was reset, the screen was blank.The device could not have been used on a patient, if needed.There was no patient use associated with the reported failure.
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Manufacturer Narrative
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(b)(4): physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Manufacturer Narrative
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Physio-control evaluated the device and verified the reported failure.The cause of the reported failure was determined to be that the user interface flex cable assembly was not fully seated into the connector on the user interface pcb assembly.Once connected, normal functionality was observed.Physio then performed unrelated repairs and observed proper device operation through functional and performance testing.The device was then returned to the customer for use.
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Search Alerts/Recalls
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