Model Number 860332 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A follow-up report will be submitted upon completion of the investigation.
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Event Description
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The customer reported that the frame was damaged from a fall.No other information was provided.The device was not in use on a patient at the time of the event.The pagewriter tc10 cardiograph (model number 860392) is substantially similar to the pagewriter tc20 cardiograph (model number 860332) and will be reported in the united states under device model number 860332 (cfn/fei # (b)(4); 510k k113144).
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Event Description
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The customer reported that the frame was damaged from a fall.The device was not in clinical use at the time the reported issue was discovered.
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Manufacturer Narrative
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A repair technician was sent to assist the customer.A good faith effort was completed to determine how the unit fell, but no response was received.It is unknown how the customer's issue was resolved.
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Search Alerts/Recalls
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