CONTRACT MEDICAL INTERNATIONAL CLEARSIGHT FINGER CUFF; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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Model Number CSCM |
Device Problems
False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Result or Readings (1535); Pressure Problem (3012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The device evaluation is anticipated and a supplemental report will be forthcoming with the evaluation results.
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Event Description
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It was reported that inaccurate pressure value was shown on the monitor when the measurement started with the clearsight finger cuff.The systolic pressure was over 200mmhg, while the expected value was around 100 to 120mmhg.The shape of the pressure waveform shown on the monitor was observed to be smooth.The patient was not treated based on the inaccurate value.Finger cuff was replaced and the problem was solved.There was no patient injury reported.
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Manufacturer Narrative
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Received one medium clearsight finger cuff.No visible damage was noticed from the returned unit.Pressure cuff inflated without any leakage during leak test which was performed both before and after decontamination.Information such as serial number, lot number, size, manufacture date of the unit were available during eeprom verification.Electrical testing also showed that all elements such as shield, led, and photodiode of returned unit were ok.Customer report of "inaccurate pressure value" was not able to be confirmed.
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Manufacturer Narrative
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Engineering evaluation results: the complaint was not confirmed.During the product evaluation, it was not possible to replicate the alleged inaccurate pressure value failure mode.Additionally, the returned finger cuff was not damaged and passed all the electrical testing performed.The finger cuff manufacturer reviewed their manufacturing records and did not find a non-conformance related to the customer complaint.Also, the patient was not treated using the complaint finger cuff as it was replaced by another finger cuff at the hospital.
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Search Alerts/Recalls
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