Model Number 865351 |
Device Problem
Inaudible or Unclear Audible Prompt/Feedback (2283)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted once the investigation is complete.
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Event Description
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The customer reported a speaker malfunction.Additional information received through follow-up confirmed that the device speakers were not functioning or producing audible alarms/ sounds/ tones.No patient involvement.
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Manufacturer Narrative
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Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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D8 updated.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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