BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMETER XPOD LP MPR

    MDR report key: 12164655 · Received July 14, 2021

    Report

    Report Number
    9612330-2021-00009
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    October 1, 2020
    Report Date
    March 9, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
    Product Code
    OLV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT#: (B)(4). EMBLETTA MPR UNIT OVERHEATED. PART 011291 OXIMETER XPOD LP MPR USED WITH MPR WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE CUSTOMER REPORTED THAT 2 MPR UNITS OVERHEATED, STATING THIS FAILURE OCCURRED A FEW DAYS BEFORE. THEY NOTED THEY CONFIRMED THAT THEY REPLACED THE AA BATTERIES DURING EACH USE, THE EMBLETTA X100 WORKS NORMALLY AND EXCLUDES THE COMPUTER. THE CUSTOMER REPORTED NO SMOKE, FLAMES OR MELTING. THEY STATED THE RECORD WAS ABNORMAL, THE PATIENT FOUND THE LOCATION ABOVE THE BATTERY COVER GETTING HOT. THE SERVICE TECHNICIAN NOTED THAT THE CUSTOMER WROTE THE DATE OF OCCURRENCE AS 10-2020. THE CUSTOMER STOPPED THE COLLECTION FOR THE NIGHT. THE SERVICE TECH REQUESTED FOR BOTH THE EMBLETTA MPRS AND THE XPOD UNITS TO BE RETURNED. THE SERVICE TECHNICIAN SET UP CASE (B)(4) FOR THE EMBLETTA WITH SERIAL NUMBER (B)(6) FOR SERIAL NUMBER (B)(6). AUG-08-2021 THE TECHNICAL SERVICE REPORTED THE 2 EMBLETTA MPRS AND OXIMETERS HAD NOT BEEN RETURNED. THE TECHNICAL SERVICE REPRESENTATIVE REACHED OUT TO HAVE ALL AFFECTED ITEMS RETURNED. AUG-12-2021 THE SALES REPRESENTATIVE REPORTED THAT THE DISTRIBUTOR REPORTED THAT THEY ARE STILL USING THE AFFECTED EMBLETTA MPRS AND THEY "ARE WORKING NORMALLY." THEY STATED THE CUSTOMER CANNOT RETURN BOTH UNITS AND NEED TO RETURN THE REPLACEMENTS. AUG-13-2021 THE SERVICE TECHNICIAN EMAILED A 2ND REQUEST FOR THE UNITS TO BE RETURNED FOR INVESTIGATION. AUG-16-2021 THE REPLACEMENT OXIMETER (505027298) WAS SHIPPED TO THE CUSTOMER TO RESOLVE THE ISSUE. JAN-21-2022 3RD REQUEST FOR RETURN OF THE DEFECTIVE UNIT. MAR-08-2022 IT HAS BEEN MORE THAN 45 DAYS SINCE THE LAST RMA SENT TO THE CUSTOMER. PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION, THEREFORE UNABLE TO VERIFY COMPLAINT. COMPLAINT WILL BE INCLUDED IN THE TRENDING DATA FOR FURTHER REVIEW PER QMS-004442. INSTALL DATE: SEP-16-2020.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT REF NATUS COMPLAINT#(B)(4). AWAITING RETURN OF THE AFFECTED PRODUCT. CORRECTION TO SECTION B1., H1., SECTION D4., INCLUDED UNIQUE IDENTIFIER (UDI):(B)(4).

    Description of Event or Problem · 0

    EMBLETTA MPR UNIT OVERHEATED. NO INJURY OR DEATH. PART 011291 OXIMETER XPOD LP MPR USED WITH MPR UNIT TO BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    EMBLETTA MPR UNIT OVERHEATED. NO INJURY OR DEATH. PART 011291 OXIMETER XPOD LP MPR USED WITH MPR UNIT TO BE RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF NATUS COMPLAINT#(B)(4). EMBLETTA MPR UNIT OVERHEATED. NO INJURY OR DEATH. PART 011291 OXIMETER XPOD LP MPR USED WITH MPR UNIT TO BE RETURNED FOR INVESTIGATION. HAZARD ID (B)(4) - PULSE OX SENSOR OVERHEATS OR IS TOO HOT FOR PATIENT CONTACT. EFFECTS (HARM) - RANGE FROM CLINICALLY INSIGNIFICANT TO IRREVERSIBLE INJURY RESULTING FROM DIRECT PHYSICAL INJURY RESIDUAL RISK= LOW AND ACCEPTABLE THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN (B)(4), HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE.

    Description of Event or Problem · 1

    EMBLETTA MPR UNIT OVERHEATED. NO INJURY OR DEATH. PART 011291 OXIMETER XPOD LP MPR USED WITH MPR UNIT TO BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065254 OXIMETER XPOD LP MPR OXIMETER XPOD LP MPR OLV NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. 011291

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown