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Model Number V200 |
Device Problem
Device Emits Odor (1425)
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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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Date of event: (b)(6) 2020.Date of report: 09jun2020.
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Event Description
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It was reported that after replacing the power supply there was an odor.There was no patient involvement.The customer troubleshot with technical support.The customer reported that the unit had been in storage and that the unit would originally not run on alternating current (ac) or battery, it would not indicate it was charging.The customer then replaced the power supply and the unit has a 'warm odor'.The customer was advised to inspect the unit internal for any thermal damage.
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Manufacturer Narrative
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G4: 15jul2020 b4: (b)(6) 2020 upon a follow-up, the customer indicated that the odor coming from the power supply went away, and there was no further issue with the odor.The customer stated having another problem with the unit with the safety valve failing during the extended self test (est).The customer will call back when available to troubleshoot with technical support.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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G4: 17aug2020.B4: 18aug2020.Multiple attempts were made to obtain information on the repair/service of the device but have been unsuccessful.A supplemental report will be submitted if new data is received.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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