NIMBUS 4
Report
- Report Number
- 3005619970-2017-00003
- Event Type
- Malfunction
- Date Received
- February 3, 2017
- Report Date
- March 3, 2017
- Manufacturer
- GETINGE (SUZHOU) CO., LTD.
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
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). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ON 04 JAN 2017 ARJOHUNTLEIGH RECEIVED AN INFORMATION FROM A PRIVATE CUSTOMER REGARDING AN EVENT WHICH OCCURRED WITH THE INVOLVEMENT OF NIMBUS 4 SYSTEM. PATIENT'S WIFE HAS INFORMED THAT HER HUSBAND'S PRESSURE SORES DEVELOPED AS A CONSEQUENCE OF PREVIOUS INCIDENTS WHICH OCCURRED IN OCTOBER AND NOVEMBER 2016 DID NOT APPEAR TO HEAL. THE MAJOR CONCERN REFERRED TO THE LACK IMPROVEMENT OF PATIENT'S CONDITION, WHICH WAS SUPPORTED BY PHOTOGRAPHIC EVIDENCE OF PATIENT'S INJURY - PRESSURE SORES APPEARED TO BE AT THE STAGE 2 (BASING ON THE PHOTOGRAPHS ONLY) BUT ACCORDING TO OUR CLINICAL EXPERT, WITHOUT THE KNOWLEDGE ABOUT OTHER ASPECTS OF PATIENT'S CARE, E.G. CHARACTERISTICS OF THE THERAPY, REGIMEN OF RE-POSITIONING, SKIN CARE AND NUTRITIONAL PLAN, IT APPEARS DIFFICULT TO EXCLUDE THE POTENTIAL FOR FURTHER DEVELOPMENT OF SORES. ALTHOUGH THE CUSTOMER EXPRESSED HER DISAPPOINTMENT AND CONCERN ABOUT A CURRENT HEALTH CONDITION OF HER HUSBAND, THIS ALLEGATION WAS NOT RELATED TO ANY PRODUCT MALFUNCTION. NO CONCERNS IN TERMS OF DEVICE FUNCTIONALITY WERE INDICATED, NO MENTION OF USE ERROR OR POTENTIALLY HAZARDOUS SYMPTOMS (E.G. MATTRESS DEFLATION). WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND TWO OTHER CASES OF EVENTS WITH THE INVOLVEMENT OF THE SAME HOMECARE PATIENT. ARJOHUNTLEIGH WAS INFORMED ABOUT BOTH PREVIOUS EVENTS IN (B)(6) 2016. THEY WERE RELATED TO USE ERROR WITH NO PRODUCT MALFUNCTION - IGNORED ALARMS WHICH TRIGGERED PRESSURE SORES FOR PATIENT. FOLLOWING THE INFORMATION GATHERED, IT WAS POSSIBLE TO INDICATE THE MOST LIKELY SCENARIO OF THE REPORTED EVENT. THE SYSTEM DID NOT REVEAL ANY MALFUNCTION AND WAS NOT THE SOURCE OF ANY AIR LEAKAGE. MATTRESS AND PUMP WERE FULLY FUNCTIONAL AND PERFORMED UP TO THEIR SPECIFICATIONS. IT WAS ESTABLISHED THAT THE SYSTEM WHICH CURRENTLY HAS BEEN WITH THE CUSTOMER WAS LATELY REPLACED AFTER THE EVENT REPORTED IN NOVEMBER NOT DUE TO MALFUNCTIONS (NO FUNCTIONAL PROBLEM NOTED AT THE TIME) BUT PREVENTIVELY IN ORDER TO ASSURE CUSTOMER'S PERSONAL LEVEL OF CONFIDENCE. FOLLOWING RECOMMENDATIONS OF THE INVESTIGATION, THE ACTION OF RE-TRAINING WAS ALSO PERFORMED FOR THIS CUSTOMER - INSTRUCTIONS IN TERMS OF THERAPY FEATURES WERE PROVIDED DURING THE LAST VISIT OF ARJOHUNTLEIGH REPRESENTATIVE WHEN APPROACHING THE FACILITY. MOREOVER, AN INFORMATIVE LETTER WITH INSTRUCTIONS WAS ISSUED ON 1 DEC 2016. TAKING INTO CONSIDERATION THE ROOT CAUSE OF PREVIOUS INCIDENTS, IT APPEARS VERY LIKELY THAT THE LACK OF IMPROVEMENT OF PRESSURE SORES REPORTED IN THE PAST WAS A RESULT OF INCORRECTLY APPLIED PRESSURE ULCER MANAGEMENT PROTOCOL. REPEATABLE USE ERRORS CANNOT BE EXCLUDED IN TERMS OF A CONTRIBUTORY FACTOR, ALTHOUGH NOT INDICATED BY THE INITIAL REPORTER. UPON THE INTERVIEW, IT WAS POSSIBLE TO ESTABLISH THAT A HOMECARE CUSTOMER IS CONFIDENT ABOUT NIMBUS 4 SYSTEM, SHARING A GENERAL POSITIVE OPINION IN TERMS OF PRODUCT'S PERFORMANCE. HOWEVER, CONCERNS WERE RAISED IN TERMS OF THE LEVEL OF KNOWLEDGE REGARDING PRODUCT'S USE. THE CUSTOMER HAD DIFFICULTIES FINDING A REASON OF PREVIOUS EVENTS (OBVIOUS EXAMPLES OF USE ERRORS, INCLUDING NO REACTION FOR THE ALARMS TRIGGERED - LOW PRESSURE AND POWER FAILURE ALARMS). NIMBUS 4 SYSTEM IS INCORPORATED WITH SEVERAL DESIGNED MITIGATION FACTORS INCLUDING DEDICATED PUMP ALARMS WHICH ARE SUPPOSED TO ALERT THE USER IN CASE OF SYSTEM MALFUNCTION WHICH MAY POSSIBLY TRIGGER A HAZARDOUS SITUATION FOR THE PATIENT. BASING ON THE CONCLUSIONS OF PREVIOUSLY REPORTED EVENTS, DESPITE A FULLY FUNCTIONAL DESIGNED MITIGATION FACTORS (A POWER FAIL AND LOW PRESSURE ALARMS) WHICH WERE ALERTING THE CAREGIVER, NO IMMEDIATE ACTION WAS TAKEN. THE REACTION OF A CAREGIVER DID NOT PREVENT PRESSURE SORES FROM WORSENING. IT APPEARS MOST LIKELY THAT THE PROBLEM IS STRICTLY RELATED TO THE PROCEDURE OF PATIENT'S MONITORING AND THE OVERALL CARE PLAN IMPLEMENTED FOR THIS PARTICULAR PATIENT WHICH CONTRIBUTED TO THE POTENTIAL RISK OF A HAZARDOUS SITUATION. NIMBUS 4 SYSTEM IS INDICATED FOR THE PREVENTION AND/OR MANAGEMENT OF ALL CATEGORIES OF PRESSURE ULCERS WHEN COMBINED WITH AN INDIVIDUALIZED, COMPREHENSIVE PRESSURE ULCER PROTOCOL, INCLUDING REPOSITIONING, NUTRITIONAL SUPPORT, SKIN CARE. SELECTION SHOULD BE BASED UPON A HOLISTIC ASSESSMENT OF THE PATIENT'S INDIVIDUAL CARE NEEDS. THE SYSTEM REPRESENTS ONLY ONE ASPECT OF PRESSURE ULCER MANAGEMENT PROTOCOL - ALL OTHER ASPECTS OF CARE SHOULD BE CONSIDERED BY THE PRESCRIBING CLINICIAN. [INSTRUCTION FOR USE, 649933EN_02] POSSIBLE SEQUENCE OF EVENTS PRESENTED ABOVE SEEMS TO BE THE MOST PROBABLE AND IN LINE WITH THE EVENT DESCRIPTION. THE ROOT CAUSE OF THE REPORTED EVENT IS CONSIDERED TO BE USE ERROR- AN INCORRECTLY APPLIED PRESSURE ULCER MANAGEMENT AND INDIVIDUAL PATIENT'S ASSESSMENT. ARJOHUNTLEIGH DECIDED TO INITIATE AN ADDITIONAL TRAINING SESSION FOR THIS CUSTOMER IN ORDER TO ASSURE A FULL ASSISTANCE IN TERMS OF THERAPY CHARACTERISTICS AND PREVENT SIMILAR EVENTS FROM RECURRENCE. IT HAS BEEN ESTABLISHED THAT THE NIMBUS 4 SYSTEM WAS BEING USED FOR A PATIENT THERAPY AT THE TIME OF THE EVENT BUT HAS NOT MALFUNCTIONED (DID PERFORM UP TO SPECIFICATION) AND HAS NOT CONTRIBUTED TO THE OUTCOME OF THE EVENT.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #(B)(4)) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. AHUS (REGISTRATION #(B)(4)).ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION CONCLUSION.
ON 04 JAN 2017 ARJOHUNTLEIGH RECEIVED AN ALLEGATION FROM A PATIENT'S WIFE CONCERNING THE THERAPY OF HER HUSBAND BEING PERFORMED WITH THE SUPPORT OF NIMBUS 4 SYSTEM. IT WAS STATED THAT THE CONDITION OF HER HUSBAND IS NOT IMPROVING AFTER PREVIOUSLY REPORTED INCIDENTS. THIS ALLEGATION WAS SUPPORTED WITH A PHOTOGRAPHIC EVIDENCE OF PRESSURE ULCERS WHICH WAS EVALUATED BY ARJOHUNTLEIGH CLINICAL EXPERT AS STAGE 2 PRESSURE ULCERS, HOWEVER, THIS ASSESSMENT WAS ONLY BASED ON THE PROVIDED PHOTOGRAPH, WITH A DOSE OF UNCERTAINTY ABOUT OTHER ASPECTS OF A CURRENT PATIENT'S CONDITION. NO MALFUNCTIONS OF NIMBUS 4 SYSTEM WERE REPORTED INITIALLY. THE SYSTEM BEEN EVALUATED BY ARJOHUNTLEIGH WITH NO FAULT FOUND.
ON (B)(6) 2017 ARJOHUNTLEIGH RECEIVED AN ALLEGATION FROM A PATIENT'S WIFE CONCERNING THE THERAPY OF HER HUSBAND BEING PERFORMED WITH THE SUPPORT OF NIMBUS 4 SYSTEM. IT WAS STATED THAT THE CONDITION OF HER HUSBAND IS NOT IMPROVING AFTER PREVIOUSLY REPORTED INCIDENTS. THIS ALLEGATION WAS SUPPORTED WITH A PHOTOGRAPHIC EVIDENCE OF PRESSURE ULCERS WHICH WAS EVALUATED BY ARJOHUNTLEIGH CLINICAL EXPERT AS STAGE 2 PRESSURE ULCERS, HOWEVER, THIS ASSESSMENT WAS ONLY BASED ON THE PROVIDED PHOTOGRAPH, WITH A DOSE OF UNCERTAINTY ABOUT OTHER ASPECTS OF A CURRENT PATIENT'S CONDITION. NO MALFUNCTIONS OF NIMBUS 4 SYSTEM WERE REPORTED INITIALLY. THE SYSTEM BEEN EVALUATED BY ARJOHUNTLEIGH WITH NO FAULT FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85053 | NIMBUS 4 | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | FNM | GETINGE (SUZHOU) CO., LTD. | 649015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |