Philips received a complaint by the customer on the v60 indicating that while the device was in use on a patient, the patient died on (b)(4) 2023, even though the patient was able to breathe spontaneously.The device kept operating when the event occurred.It was confirmed that the device was being used as it was with no medical intervention taken at the time of the event.No other patient information was disclosed.The hospital did not report any causal relationship, but as the patient's family stated that a cause on the device side may have led to the death.It was confirmed that the device was being used as intended with no medical intervention taken at the time of the event.The hospital did not report any causal relationship, but as the patient's family stated that a cause on the device side may have led to the death.The medical engineer evaluated the device and based on the information currently provided and available, the manufacturer is unable to positively refute any allegation of device malfunction or failure to perform to manufacturer declared specifications due to the absence of device logs at the time of the event in question.It is possible that cause and/or contribution of the device to the patient outcome was present, however, without further substantiating evidence this cannot be confirmed.Further good faith efforts yielded no additional information of clinical relevance in determining the presence of an alleged device malfunction.The device diagnostic report was retrieved and reviewed finding no error or malfunctions, however, due to the device capacity to record only the last 2000 events, the specific date of the event in question could not be reviewed in the report.The device was retrieved and inspected with determination that no parts required replacement.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
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Further good faith efforts and investigation yielded information stating that the device underwent functionality testing with no malfunction or failure to perform to manufacturer declared specifications, resolving any allegation lodged by the decedent's surviving family of device cause and/or contribution to the patient outcome.No further action is currently required.The complaint record has been amended to reflect this new information and the determination by the pms clinical expert is to disposition the complaint record as a patient death with no cause and/or contribution of the device to the patient outcome as supported by functionality testing and redaction of the allegation by the patient's family.Based on information provided and/or service performed, the device didn't fail to meet manufacturing specifications.The device was being used for treatment when the reported event occurred.
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