BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS 3

    MDR report key: 7905275 · Received September 25, 2018

    Report

    Report Number
    3005619970-2018-00011
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    June 30, 2018
    Report Date
    September 25, 2018
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #3005619970) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. AHUS (REGISTRATION #1419652). IT WAS FOUND THAT THIS REPORT WAS INITIALLY REPORTED UNDER MFR#3007420694-2018-00145 AND IMPORTER #1419652-2018-00220. THE ORIGINAL MFR# WAS SELECTED INCORECTLY. THEREFORE A NEW MFR #3005619970-2018-00011 HAS BEEN ASSIGNED TO THIS REPORT. THE ORIGINAL IMPORTER REPORT # 1419652-2018-00220 IS CORRECT AND REMAINS UNCHANGED. CORRECTIONS WERE MADE IN FIELDS: D3, D4, F14, G1.2 (CONTINUED). THE INVESTIGATION HAS BEEN CARRIED OUT TO THIS COMPLAINT AND THE CONCLUSIONS ARE FOLLOWING. ARJO WAS NOTIFIED ABOUT AN INCIDENT INVOLVING NIMBUS 3 MATTRESS. IT WAS REPORTED THAT NIMBUS MATTRESS HAS DEFLATED DURING PATIENT'S THERAPY. THE PATIENT REMAINED ON A DEFLATED MATTRESS FOR AN UNKNOWN PERIOD OF TIME, UNTIL THE SERVICE WAS PERFORMED. DUE TO UNKNOWN REASON, THE PATIENT WAS LEFT ON A DEFECTIVE PRODUCT DURING THE REPAIR. UPON DEVICE EVALUATION IT WAS FOUND THAT ONE OF THE TORSO CELLS WAS LEAKING. THE COMPONENT WAS REPLACED, HOWEVER, LATER ON THE SAME DAY THE SYSTEM REVEALED A MALFUNCTION AGAIN - LOW PRESSURE CONDITION OCCURRED. NEW MATTRESS WAS DELIVERED, YET THE DAUGHTER REFUSED THE ARJO MATTRESS BE PLACED WITH HER FATHER. THE PATIENT WAS TRANSFERRED TO ANOTHER MATTRESS AND BED. THERE WAS NO PATIENT INJURY. ACCORDING TO THE DAUGHTER HER FATHER, WHO WAS VENTILATED FELT ADDITIONAL PAIN DUE TO THE DEFECTIVE AIR MATTRESS. NO INFORMATION HAS BEEN PROVIDED BY THE NURSE INVOLVED IN THE INCIDENT. BEFORE THE SYSTEM (PUMP AND MATTRESS) WAS RENTED TO THE CUSTOMER, IT WAS QUALITY CONTROL CHECKED AND NO FAULT CONDITION WAS FOUND, THE SYSTEM MET MANUFACTURER'S SPECIFICATION. WHEN THE MATTRESS RETURNED TO SERVICE CENTER, DURING QUALITY CONTROL PROCESS ADDITIONAL 2 CELLS WERE REPLACED. ACCORDING TO ARJO SERVICE TECHNICIAN CELL HAD A LEAK AROUND THE CONNECTOR DUE TO WEAR AND TEAR. THE DECISION TO LEFT THE PATIENT ON THE MATTRESS DURING A REPAIR MIGHT HAVE INFLUENCED THE REPAIR ITSELF AND ITS EFFICIENCY. ACCORDING TO THE ARJO TECHNICIAN, ALARM WAS FUNCTIONING CORRECTLY. THE PUMP DID NOT REQUIRE REPAIRING, ONLY MATTRESS CELLS WERE REPLACED. IN CASE THE PUMP DETECTS LOW PRESSURE WITHIN THE MATTRESS, THE LOW PRESSURE INDICATOR WILL ILLUMINATE SUGGESTING THAT THERE IS INSUFFICIENT PRESSURE TO SUPPORT A PATIENT AND WARNING A CAREGIVER TO MINIMIZE ANY HAZARDOUS SITUATION. THE PATIENT'S DAUGHTER STATED THAT IT IS UNKNOWN HOW LONG HER FATHER WAS LAYING ON THE DEFLATED MATTRESS. FROM THE MOMENT MATTRESS FAILURE WAS DETECTED TO ITS INITIAL REPAIR, 2 HOURS HAS PASSED. THE PATIENT WAS LAYING ON THE FAULTY MATTRESS UNTIL WAS TRANSFERRED TO ANOTHER BED AND MATTRESS APPROXIMATELY AFTER ADDITIONAL 2-3 HOURS. BOTH ISSUE COULD HAVE COMPROMISED PATIENT'S HEALTH CONDITION: REPAIR PERFORMED WITH A PATIENT ON THE MATTRESS AND LEAVING THE PATIENT ON THE DEFECTIVE MATTRESS FOR UNKNOWN PERIOD (POSSIBLY 4-5 HOURS). IT IS THE RESPONSIBILITY OF THE CAREGIVER TO ASSESS PATIENTS FREQUENTLY AND AS SOON AS THE FAULT IS DISCOVERED, THE PATIENT SHOULD HAVE BEEN MOVED TO ANOTHER SURFACE. IT IS UNKNOWN WHY THE PATIENT WAS NOT TRANSFERRED TO ANOTHER SURFACE WHEN THE FAULT WAS DETECTED, IT IS SUSPECTED THAT PATIENT MEDICAL CONDITION MIGHT HAVE INFLUENCED THE DECISION. INSTRUCTION FOR USE STATES: "THE NIMBUS 3 [...] SYSTEMS ARE INDICATED FOR THE PREVENTION AND MANAGEMENT OF ALL CATEGORIES OF PRESSURE ULCER WHEN COMBINED WITH AN INDIVIDUALIZED MONITORING, REPOSITIONING AND WOUND CARE PROGRAMME". THE ROOT CAUSE FOR THE LEAKING CELL CAN BE DEEMED AS NORMAL WEAR AND TEAR, HOWEVER, THE IMPLEMENT PROCEDURE OF PATIENT'S CARE (PATIENT REMAINED ON A DEFECTIVE MATTRESS) HAS CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED MALFUNCTION ITSELF (CELL LEAKAGE) IS NOT CONSIDERED REPORTABLE. THE SYSTEM IS EQUIPPED WITH A SOPHISTICATED ALARM SYSTEM, WHICH IS ACTIVATED WHEN ALARM SITUATION OCCURS. A FLASHING INDICATOR WILL ILLUMINATE, TOGETHER WITH AN INDICATION OF THE CAUSE OF ALARM, AND AN AUDIBLE WARNING WILL SOUND. IN SUMMARY, THE MATTRESS WAS USED FOR A PATIENT TREATMENT WHEN THE EVENT OCCURRED AND THEREFORE PLAYED A ROLE IN THE INCIDENT. THE MATTRESS FAILED TO PERFORM ITS SPECIFICATION. WHEN ANY PRODUCT MALFUNCTION IS DETECTED, THE PRODUCT SHOULD BE WITHDRAWN FROM USE UNTIL THE SERVICE IS PERFORMED. THE INVESTIGATED EVENT PRESENTS A SCENARIO IN WHICH THE PATIENT WAS LEFT ON THE DEFECTIVE MATTRESS AND REMAINED THERE ALSO DURING THE SERVICING PROCEDURE. FOLLOWING THE INFORMATION GATHERED, A SPECIFIC REGIMEN OF PATIENT CARE IS CONSIDERED TO BE A RISK FACTOR WHICH COULD HAVE COMPROMISED PATIENT'S SAFETY. FOR THIS REASON IT WAS DECIDED TO REPORT THIS INCIDENT IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RESUBMITTED AS PER THE REQUEST BY MDR DATA SYSTEMS TEAM, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH. THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O. O. (REGISTRATION #(B)(4)) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION #(B)(4)PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED AB (UNDER REGISTRATION #(B)(4)). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RESUBMITTED AS PER THE REQUEST BY MDR DATA SYSTEMS TEAM, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH. THIS FOLLOW-UP REPORT IS TO INFORM YOU ABOUT PROGRESS MADE THUS FAR. THERE WAS NO DEFECT FOUND WITHIN THE PUMP, ACCORDING TO AN ARJO TECHNICIAN AN ALARM WAS WORKING PROPERLY. THIS SYSTEM IS EQUIPPED WITH AN ALARM WHICH IS ACTIVATED WHEN THE PUMP DETECTS LOW PRESSURE WITHIN THE MATTRESS ALERTING A CAREGIVER TO TAKE AN APPROPRIATE ACTIONS. THE PATIENT'S DAUGHTER STATED THAT IT IS UNKNOWN HOW LONG HER FATHER WAS LAYING ON THE DEFLATED MATTRESS. IT IS ESTIMATED THAT THE PATIENT WAS NOT TRANSFER TO THE OTHER MATTRESS IMMEDIATELY WHEN THE FAULT WAS DETECTED BY COULD HAVE BEEN LAYING ON THE FAULTY MATTRESS APPROXIMATELY 4 -5 HOURS. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY PATIENT'S DAUGHTER THAT HER FATHER WAS LAYING ON A DEFLATED MATTRESS FOR UNKNOWN TIME. A PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6)2018. ON (B)(6)2018 IT WAS NOTICED THAT THE PATIENT WAS SINKING IN THE MIDDLE OF THE BED. AN ARJO REPRESENTATIVE REPAIRED A LEAKING CELL. LATER THE SAME DAY IT WAS NOTICED THAT THE MATTRESS REQUIRED ANOTHER REPAIR. PATIENT WAS TRANSFERRED TO ANOTHER BED. THE MATTRESS RETURNED TO ARJO SERVICE CENTER, WHERE TWO ADDITIONAL CELLS WERE REPLACED. IT WAS REPORTED THAT THE PATIENT WAS SUBJECTED TO ADDITIONAL DISCOMFORT AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749599 NIMBUS 3 MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM GETINGE (SUZHOU) CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Other