Model Number 00-3020 |
Device Problems
Device Sensing Problem (2917); Incomplete or Inadequate Connection (4037)
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Patient Problems
Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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It has been reported to philips the ls failed to read therapy pads when placed on patient.
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Manufacturer Narrative
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Type of reported complaint -changed to serious injury and adverse event.
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Manufacturer Narrative
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This report is based on information provided by philips repair service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that the device failed to read therapy pads when placed on patient.The complaint was escalated for technical investigation and the results indicate that there is no abnormal behaviour in the log regarding the device's function.It may be assumed that the device works well when it is connected to a simulator.Rdt has tested the device and they could not identify any malfunction.Therefore, it may be assumed that the unit worked as intended.No malfunction of the device has been detected, device worked as intended.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.
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Manufacturer Narrative
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Updated investigation summary: this report is based on information provided by philips remote service engineer and schiller investigation team and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that the device failed to read therapy pads when placed on patient.Patient in cardiac arrest.Patient outcome, delivered to ed with pulses.The complaint was escalated for technical investigation, the logs sent to schiller, and the results indicate that there is no abnormal behavior in the log regarding the device's function.The suspicion is that the pads might have not been attached properly.Rdt investigation: log and rescue files(dated (b)(6) 2023) analyzed and measured impedance values were varying very often, varying from too low(less than 25o) to too high (greater than 250 o) and finally stabilized at 110o.Initial variation of impedance values beyond acceptance range resulted in "check defib electrodes" message.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The device was confirmed to be operating per specifications and no failure was identified.If additional information is received the complaint file will be reopened.
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Search Alerts/Recalls
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