Model Number M3535A |
Device Problems
Failure to Calibrate (2440); Failure of Device to Self-Test (2937)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/04/2023 |
Event Type
malfunction
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Event Description
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It was reported to philips that the equipment failed the op check for co2 calibration.There was no reported patient involvement.
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Manufacturer Narrative
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Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
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Manufacturer Narrative
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This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx defibrillator indicating that the device failed for co2 calibration.Based on the information available, a quote was provided for a field service engineer to visit the customers site and perform the co2 calibration.A quote was provided to the customer for co2 calibration but has not been accepted.The device does not meet full specifications and is not returned to use.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : quote provided for service but not accepted.
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Search Alerts/Recalls
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