Catalog Number 0055502 |
Device Problem
Battery Problem (2885)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 08/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product usage when the alleged issue was detected is unknown.The device sample was not returned for evaluation at the time of this report.
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Event Description
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The customer alleges that the battery is either broken or has failed.No patient injury reported.
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Manufacturer Narrative
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(b)(4).A device history record (dhr) review was performed reviewed on the lot number of the sample received (1451v3) and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample was returned for evaluation.A visual exam and functional testing was performed and the unit was working well and was able to be charged.It was found that the expiration date of the device was may 2016, so the it was expired prior to the complaint.
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Event Description
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The customer alleges that the battery is either broken or has failed.No patient injury reported.
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Search Alerts/Recalls
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