BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 6225044 · Received January 5, 2017

    Report

    Report Number
    3007420694-2017-00002
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    December 2, 2016
    Report Date
    December 8, 2016
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9611530 OR MEDIBO (MEDIBO MEDICAL PRODUCTS NV / 3004468271) AND AH MAGOG (ARJOHUNTLEIGH MAGOG INC. / 9681684). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. NONE OF PREVIOUSLY REPORTED EVENTS WITHIN LAST 5 YEARS (EXCEPT FOR THE CURRENT INCIDENT) WAS RELATED TO THE ISSUE INVESTIGATED HERE - SPREADER BAR BROKEN METAL PARTS CONTRIBUTING TO AN INJURY. THIS EVENT IS CONSIDERED TO BE AN ISOLATED CASE TO DATE. PLEASE NOTE THAT ARJOHUNTLEIGH MANUFACTURED OVER (B)(4) TEMPO PASSIVE FLOOR LIFTS. IF COMPARED TO THE NUMBER OF SOLD DEVICES AND IN COMPARISON TO THEIR DAILY USE THE OCCURRENCE RATE OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW. AS REPORTED BY THE CUSTOMER, THE RESIDENT (FEMALE, (B)(6)) WAS BEING TRANSFERRED FROM THE BED INTO THE SHOWER CHAIR UTILIZING THE TEMPO PASSIVE FLOOR LIFT - NOTHING ABNORMAL OR CONCERNING WAS NOTICED AT THAT TIME. HOWEVER, WHILE SHOWERING HER AFTER THE TRANSFER, AT THE MOMENT WHEN HER LEFT ARM WAS LIFTED, SHE SCREAMED DUE TO PAIN. AFTER THAT THE RESIDENT WAS TAKEN TO HOSPITAL WHERE SHE WAS TREATED FOR FULL LEFT DISTAL HUMERUS FRACTURE (CAST WAS APPLIED ON LEFT ARM WITH SLING; PAIN MANAGEMENT). THE FACILITY STAFF COMMENTED THAT AFTER THEIR INTERNAL INVESTIGATION OF THE INCIDENT, IT HAS BEEN REVEALED THAT THE INCIDENT WAS CAUSED BY THE TEMPO SPREADER BAR DUE TO BROKEN BOLT AND DAMAGED HARDWARE. WHEN THE CAREGIVER WAS ABOUT TO USE THE INVOLVED LIFT WITH ANOTHER RESIDENT, SHE NOTICED BROKEN METAL PART ON THE FLOOR AND STOP USING THE LIFT. TAKING INTO ACCOUNT THE LISTED BELOW FACTS, IT IS FOUND THE DEVICE WAS BEING USED FOR TREATMENT OF THE PATIENT WHEN THE EVENT OCCURRED AND IT WAS ALSO DIRECTLY INVOLVED WITH THE ADVERSE EVENT AS THE SERIOUS INJURY HAS OCCURRED - THE FRACTURED BONE. THE LIFT WAS INSPECTED BY ARJOHUNTLEIGH SERVICE REPRESENTATIVE. IT WAS FOUND IN GENERAL POOR CONDITION. THE SPREADER BAR HAD MULTIPLE DAMAGES AND SIGNS OF WEAR (DESCRIBED AS LOOSE/HANGING/MISSING HARDWARE). THE SPREADER BAR LEVER WAS FOUND BROKEN AND NOT ABLE TO TILT SAFELY. PER THE INSPECTION, IT WAS CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATION AT THE TIME OF THE INCIDENT. THE DEVICE IS NOT UNDER ARJO SERVICE/MAINTENANCE CONTRACT. MAINTENANCE AND REPAIRS WERE DONE IN-HOUSE BY THE CUSTOMER. THERE IS NO RECORD OF SERVICE OR REPAIR DOCUMENTED. IN COURSE OF MANUFACTURER'S INVESTIGATION IT WAS TRIED TO ESTABLISH THE MOST LIKELY ROOT CAUSE OF THE REPORTED FAILURE - SPREADER BAR BROKEN METAL PARTS CONTRIBUTING TO AN INJURY SUSTAINED BY THE RESIDENT. IT IS WORTH NOTING THAT THE INVOLVED LIFT HAS EXCEEDED ITS RECOMMENDED OPERATIONAL LIFETIME FOR OVER ONE YEAR (IT WAS MANUFACTURED IN MARCH 2005) AND SHOULD NOT BE USED FOR PATIENT TREATMENT ANY LONGER. ACCORDING TO THE OPERATING AND PRODUCT CARE INSTRUCTIONS FOR TEMPO: "THE EXPECTED OPERATIONAL LIFE OF THE ARJO LIFT IS 10 (TEN) YEARS FROM THE DATE OF MANUFACTURE, PROVIDING THAT THE FOLLOWING CONDITIONS ARE ADHERED TO". IT IS MOST LIKELY THAT THE BROKEN OR LOOSE PARTS OF THE SPREADER BAR COULD HAVE COME IN CONTACT WITH RESIDENT'S BODY CONTRIBUTED TO THE RESIDENT'S INJURY REQUIRING CAST WITH SLING TO BE APPLIED TO HER ARM. THE OPERATING AND PRODUCT CARE INSTRUCTIONS FOR TEMPO WARNS A PROPER WAY OF THE PATIENT HANDLING IN ORDER TO PREVENT THIS KIND OF INCIDENTS: "WARNING: FOR THE PROTECTION OF PATIENT AND ATTENDANT, ALWAYS ENSURE, WHEN USING THIS EQUIPMENT, THAT NO PART OF THE PATIENT'S OR ATTENDANT'S BODY IS ALLOWED TO COME IN CONTACT WITH CONNECTING OR TOUCHING PARTS OF THE LIFT AND/OR ATTACHMENTS DURING OPERATION." THE DEDICATED INSTRUCTION FOR USER WARNS THE CUSTOMER ALSO: "THE FOLLOWING CHECKS SHOULD BE CARRIED OUT DAILY: (...) CAREFULLY INSPECT ALL PARTS, IN PARTICULAR WHERE THERE IS PERSONAL CONTACT WITH THE PATIENT'S BODY. ENSURE THAT NO CRACKS OR SHARP EDGES HAVE DEVELOPED WHICH COULD INJURE THE PATIENT'S SKIN OR BECOME UNHYGIENIC. CHECK THAT ALL EXTERNAL FITTINGS ARE SECURE AND THAT ALL SCREWS AND NUTS ARE TIGHT." FURTHERMORE: "TO BE CARRIED OUT AT WEEKLY INTERVALS: PERIODIC TESTING OF THE OPERATIONAL FUNCTIONS IS ADVISABLE FROM TIME TO TIME TO ENSURE EVERYTHING OPERATES SATISFACTORILY. "GENERAL LIFT CONDITION: CARRY OUT A GENERAL VISUAL INSPECTION OF ALL EXTERNAL PARTS AND TEST ALL FUNCTIONS FOR CORRECT OPERATION, TO ENSURE THAT NO DAMAGE HAS OCCURRED DURING USE. WARNING: IF IN DOUBT ABOUT THE CORRECT FUNCTIONING OF THE TEMPO, DO NOT USE IT AND CONTACT THE ARJO SERVICE DEPARTMENT." BASED ON THE EVENT DESCRIPTION, PROVIDED PHOTOS AND THE SERVICE TECHNICIAN CONCLUSIONS, IT APPEARS THAT THE TEMPO LIFT WAS NOT CORRECTLY MAINTAINED BY THE CUSTOMER AND THE INSTRUCTION FOR USE WAS NOT FOLLOWED. FROM THE GATHERED INFORMATION IT CAN BE POINTED OUT THAT THE MOST LIKELY ROOT CAUSE OF THE PROBLEM IS RELATED TO THE CUSTOMER MISUSE (IN PARTICULAR NEGLECTED MAINTENANCE/SERVICE OF THE DEVICE AND NOT FOLLOWING THE OPERATING AND PRODUCT CARE INSTRUCTIONS PROVIDED BY THE MANUFACTURER). LOOKING AT THE INCIDENT SCENARIO, THE TEMPO PASSIVE FLOOR LIFT WAS BEING USED FOR TREATMENT OF THE PATIENT WHEN THE EVENT OCCURRED AND IT WAS DIRECTLY INVOLVED WITH THE ADVERSE EVENT AS THE SERIOUS INJURY HAS OCCURRED - THE FRACTURED BONE. PER THE DEVICE INSPECTION, IT WAS CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATION AT THE TIME OF THE INCIDENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE CUSTOMER TO ARJOHUNTLEIGH ON (B)(6) 2016, THE RESIDENT ((B)(6)) WAS BEING TRANSFERRED FROM THE BED INTO THE SHOWER CHAIR UTILIZING THE TEMPO PASSIVE FLOOR LIFT - NOTHING ABNORMAL OR CONCERNING WAS NOTICED AT THAT TIME. HOWEVER, WHILE SHOWERING HER AFTER THE TRANSFER, WHEN HER LEFT ARM WAS LIFTED, SHE SCREAMED DUE TO PAIN. AFTER THAT THE RESIDENT WAS TAKEN TO HOSPITAL WHERE SHE WAS TREATED FOR FULL LEFT DISTAL HUMERUS FRACTURE (CAST WAS APPLIED ON LEFT ARM WITH SLING; PAIN MANAGEMENT). THE FACILITY STAFF COMMENTED THAT AFTER THEIR INTERNAL INVESTIGATION OF THE INCIDENT, IT HAS BEEN REVEALED THAT THE INCIDENT WAS CAUSED BY THE TEMPO SPREADER BAR DUE TO BROKEN BOLT AND DAMAGED HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8967 TEMPO NON-AC-POWERED PATIENT LIFT FSA ARJO MED. AB LTD. KPA5010

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization