BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX HARDWARE

    MDR report key: 13862021 · Received March 23, 2022

    Report

    Report Number
    1218950-2022-00239
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 25, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL SPECIALIST (RCS) SPOKE WITH THE CUSTOMER. THE RCS REVIEWED THE ALARM REVIEW . NO PATIENT STRIP WAS PROVIDED. THE RCS NOTED AT 09:21:24 THE SPO2 PARAMETER WAS TURNED OFF AND IT WAS TURNED BACK ON AT 09:21:38 ON (B)(6) 2022. THE NEXT ENTRY IS DESATURATION OF 57% AT 09:56 WHICH ENDED AT 09:57. THERE WAS NO SPO2 ALARM ENTRY FOUND AT APPROXIMATELY 09:30 HOURS. ON (B)(6) 2022 10:33:00, (B)(4), DESAT 76 < 80 GENERATED AT 10:32:47, PIC IX: WRXPCU. ON (B)(6) 2022 10:32:43,(B)(4), DESAT 76 < 80 GENERATED AT 10:32:47, PIC IX: PCUCLNT. ON (B)(6) 2022 10:29:55, (B)(4), SILENCE, WRXPCU. ON (B)(6) 2022 10:27:14, (B)(4), SILENCE, WRXPCU. ON (B)(6) 2022 10:12:44, (B)(4), SILENCE, WRXPCU. ON (B)(6) 2022 09:57:34, (B)(4) , PULSE -PULSE FROM OFF TO ON, MPCU6. ON (B)(6) 2022 09:57:34, (B)(4), SPO2 FROM OFF TO ON, MPCU6. ON (B)(6) 2022 09:57:21, (B)(4), PULSE -PULSE FROM OFF TO ON, MPCU6. ON (B)(6) 2022 09:57:21, (B)(4), SILENCE, MPCU6. ON (B)(6) 2022 09:57:21, (B)(4), SPO2 - FROM ON TO OFF, MPCU6. ON (B)(6) 2022 09:57:20, (B)(4), DESAT 57 < 80 ENDED, PIC IX: WRXPCU. ON (B)(6) 2022 09:57:04, (B)(4), DESAT 57 < 80 ENDED, PIC IX: PCUCLNT. ON (B)(6) 2022 09:57:20, (B)(4), SILENCE MPCU6. ON (B)(6) 2022 09:57:03, (B)(4), DESAT 57 < 80 GENERATED AT 09:56:52, PIC IX: WRXPCU. ON (B)(6) 2022 09:56:46, (B)(4), DESAT 57 < 80 GENERATED AT 09:56:52, PIC IX: PCUCLNT. ON (B)(6) 2022 09:21:38, (B)(4), PULSE -PULSE FROM OFF TO ON, MPCU6. ON (B)(6) 2022 09:21:38,(B)(4), SPO2- FROM OFF TO ON, MPCU6. ON (B)(6) 2022 09:21:25, (B)(4), SPO2 - ALARMS FROM OFF TO ON, MPCU6. ON (B)(6) 2022 09:21:24, (B)(4), PULSE -PULSE FROM ON TO OFF, MPCU6. ON (B)(6) 2022 09:21:24, (B)(4), SPO2 - FROM ON TO OFF, MPCU6. ON (B)(6) 2022 09:20:51, (B)(4), SILENCE, MPCU6. ON (B)(6) 2022 09:07:07, (B)(4), SILENCE, MPCU6. ON (B)(6) 2022 08:44:53, (B)(4), SILENCE, MPCU6. ON (B)(6) 2022 08:24:26, (B)(4), SILENCE, MPCU6. ON (B)(6) 2022 08:09:00, (B)(4), SILENCE, WRXPCU. ON (B)(6) 2022 08:08:58, (B)(4), SILENCE, WRXPCU. ON (B)(6) 2022 07:22:39, (B)(4), SILENCE, WRXPCU. A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION ASSOCIATED WITH THIS COMPLAINT EVALUATION, BUT ATTEMPTS HAVE BEEN UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS LATER OBTAINED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ON (B)(6) 2022 AT APPROX. 0930 HOURS, THE ROOM #PCU 6 PATIENT HAD A DESATURATION EVENT OF 65% AND IT DID NOT ALARM. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ON (B)(6) 2022 AT APPROX. 0930 HOURS, THE ROOM#: (B)(4) PATIENT HAD A DESATURATION EVENT OF 65% AND IT DID NOT ALARM THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562192 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS NORTH AMERICA LLC 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown