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Model Number HL-90 |
Device Problem
Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2021 |
Event Type
malfunction
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Event Description
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It was reported the device had "temperature issues".Issue was found during preventive maintenance; no patient involved.
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Manufacturer Narrative
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Device evaluation- the device was returned for evaluation.The device was given functional testing and this showed the over temperature alarm was out of calibration.However the reported issue was not confirmed; the over temperature alarm was successfully calibrated.
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Event Description
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Additional information received via email 02-nov-2021: date of event updated, the reported issue did not occur while in use with a patient, and there was no adverse event.
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Manufacturer Narrative
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Other, other text: additional:d4 udi is unknown.No product information has been provided to date.B5,, d5, h6.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with a cracked enclosure underneath the drain fitting, contained old style printed circuit board (pcb), drain fitting, and line cord.The enclosure has normal wear and tear.The technician attempted to calibrate with temperature check e5768 due (b)(6) 2022.The reported issue was not confirmed.The overtempt pot r106 was raised extremely high, but managed to perform calibration.The root cause of the reported issue was found to be the technician or users inability to perform calibration.No action taken due to the age and condition.Unit will be scrapped.
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Event Description
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Additional information received via email 02-nov-2021: date of event updated, the reported issue did not occur while in use with a patient, and there was no adverse event.
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Manufacturer Narrative
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This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with a cracked enclosure underneath the drain fitting, contained old style printed circuit board (pcb), drain fitting, and line cord.The enclosure has normal wear and tear.The technician attempted to calibrate with temperature check e5768 due (b)(6) 2022.The reported issue was not confirmed.The overtempt pot r106 was raised extremely high, but managed to perform calibration.The root cause of the reported issue was found to be the technician or users inability to perform calibration.No action taken due to the age and condition.Unit will be scrapped.
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Search Alerts/Recalls
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