Model Number IRC5PO2 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Should additional information become available, a supplemental record will be filed.
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Event Description
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(b)(4) 2015 per further conversation with (b)(6), the unit was being repaired because the unit alarms were not functional.During the replacement of the power switch (aka relay or on/off switch), the wires broken when repair person tried to reconnect.The dealer stated the unit has wiring issues.
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Manufacturer Narrative
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Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the power switch was defective, causing the unit to power up intermittently.However, there was no indication of a malfunction of the alarms or wiring issues, so the original complaint issue was not confirmed.
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Event Description
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(b)(4) 2015 per further conversation with (b)(6), the unit was being repaired because the unit alarms were not functional.During the replacement of the power switch (aka relay or on/off switch), the wires broken when repair person tried to reconnect.The dealer stated the unit has wiring issues.
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Search Alerts/Recalls
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