MAGIC MOBILITY EXTREME 8
Report
- Report Number
- 3019677893-2022-00001
- Event Type
- Malfunction
- Date Received
- November 28, 2023
- Date of Event
- May 2, 2022
- Report Date
- November 29, 2023
- Manufacturer
- SUNRISE MEDICAL
- Product Code
- ITI
- PMA / PMN Number
- K211574
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BACKGROUND: THIS CHAIR IS A MAGIC MOBILITY PRODUCT. SUNRISE MEDICAL IS THE DISTRIBUTER. MAGIC MOBILITY, AUSTRALIA MAINTAINS THE DESIGN CONTROL AND ALL PRODUCT RISK DOCUMENTS. DISCUSSION: IN REVIEWING THE COMPLAINT, THE DEALER REPORTS THAT WHILE THE USER WAS OUT DRIVING, THEIR CHAIR STOPPED RUNNING. WHILE INSPECTING THE CHAIR, THE DEALER REPORTS THAT THE FUSE CABLE FOR THE BATTERIES WERE ALLEGEDLY BURNT HALFWAY THROUGH AND THAT THERE WAS A MELTED SPOT ON THE BATTERY LID. THE DEALER STATES THAT THE BATTERY CONNECTORS WERE LOOSE AND THAT THE BURN HAPPENED BETWEEN THE BATTERY AND THE FUSE. THE ROOT CAUSE FOR THE EVENT IS POSSIBLY RELATED TO A POOR CONNECTION BETWEEN THE FUSE TAG AND THE BATTERY TERMINAL. THE POOR CONNECTION COULD POTENTIALLY LEAD TO HIGH TEMPERATURES, LEADING TO BURNING. THE POOR CONNECTION IS MOST LIKELY DUE TO IMPROPER ASSEMBLY OF THE DEVICE. THERE WERE NO INJURIES REPORTED. THE PARTS INVOLVED HAVE NOT BEEN RETURNED TO SUNRISE MEDICAL FOR EVALUATION AS OF THIS FILING. CONCLUSION: WHILE THERE IS NO INJURY REPORTED, DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR, OUT OF AN ABUNDANCE OF CAUTION, AN MDR IS BEING FILED. IF THE PARTS ARE RETURNED AND THE PRODUCT EVALUATION PRODUCES ADDITIONAL FINDINGS, A SUPPLEMENTAL REPORT WILL BE FILED ADDITIONAL NOTE: THE ORIGINAL MDR WAS SUBMITTED ON (5/31/2022) WITHIN THE 30-DAY REQUIREMENT DEFINED IN 21 CFR 803 WITH A SUCCESSFUL ACKNOWLEDGEMENT 1 AND 2, HOWEVER IT WAS IDENTIFIED THAT ACKNOWLEDGEMENT 3 INDICATED THAT THE SUBMISSION FAILED AND WAS NOT ENTERED IN THE CDRH DATABASE. IT WAS FOUND THAT THE CAUSE OF THIS FAILURE WAS ATTRIBUTED TO AN ERROR IN THE MANUFACTURER NUMBER AND A LACK OF CLEAR GUIDANCE FOR VERIFYING SUCCESSFUL SUBMISSION IN THE ORGANIZATION'S PROCEDURES. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED CORRECTING THE MANUFACTURER NUMBER IN THE ORGANIZATION'S PROCEDURES AND DEFINING THE STEPS REQUIRED TO VERIFY SUCCESSFUL ENTRY INTO THE CDRH DATABASE. WHILE THE ORIGINAL SUBMISSION WAS ON-TIME, THIS FILING IS BEING MADE BECAUSE THE ORIGINAL SUBMISSION WAS NOT SUCCESSFULLY ENTERED INTO THE CDRH DATABASE WITHIN THE 30-DAY SUBMISSION REQUIREMENT. THIS SUPPLEMENTAL REPORT IS BEING FILED TO CORRECT THE MANUFACTURER'S ADDRESS IN SECTION D FROM THE FRESNO MANUFACTURING FACILITY (2842 N BUSINESS PARK AVE, FRESNO, CALIFORNIA 93727) TO THE NASHVILLE MANUFACTURING FACILITY (12002 VOLUNTEER BLVD, MOUNT JULIET, TENNESSEE 37122).
BACKGROUND: THIS CHAIR IS A MAGIC MOBILITY PRODUCT. SUNRISE MEDICAL IS THE DISTRIBUTER. MAGIC MOBILITY, AUSTRALIA MAINTAINS THE DESIGN CONTROL AND ALL PRODUCT RISK DOCUMENTS. DISCUSSION: IN REVIEWING THE COMPLAINT, THE DEALER REPORTS THAT WHILE THE USER WAS OUT DRIVING, THEIR CHAIR STOPPED RUNNING. WHILE INSPECTING THE CHAIR, THE DEALER REPORTS THAT THE FUSE CABLE FOR THE BATTERIES WERE ALLEGEDLY BURNT HALFWAY THROUGH AND THAT THERE WAS A MELTED SPOT ON THE BATTERY LID. THE DEALER STATES THAT THE BATTERY CONNECTORS WERE LOOSE AND THAT THE BURN HAPPENED BETWEEN THE BATTERY AND THE FUSE. THE ROOT CAUSE FOR THE EVENT IS POSSIBLY RELATED TO A POOR CONNECTION BETWEEN THE FUSE TAG AND THE BATTERY TERMINAL. THE POOR CONNECTION COULD POTENTIALLY LEAD TO HIGH TEMPERATURES, LEADING TO BURNING. THE POOR CONNECTION IS MOST LIKELY DUE TO IMPROPER ASSEMBLY OF THE DEVICE. THERE WERE NO INJURIES REPORTED. THE PARTS INVOLVED HAVE NOT BEEN RETURNED TO SUNRISE MEDICAL FOR EVALUATION AS OF THIS FILING. CONCLUSION: WHILE THERE IS NO INJURY REPORTED, DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR, OUT OF AN ABUNDANCE OF CAUTION, AN MDR IS BEING FILED. IF THE PARTS ARE RETURNED AND THE PRODUCT EVALUATION PRODUCES ADDITIONAL FINDINGS, A SUPPLEMENTAL REPORT WILL BE FILED ADDITIONAL NOTE: THE ORIGINAL MDR WAS SUBMITTED ON (5/31/2022) WITHIN THE 30-DAY REQUIREMENT DEFINED IN 21 CFR 803 WITH A SUCCESSFUL ACKNOWLEDGEMENT 1 AND 2, HOWEVER IT WAS IDENTIFIED THAT ACKNOWLEDGEMENT 3 INDICATED THAT THE SUBMISSION FAILED AND WAS NOT ENTERED IN THE CDRH DATABASE. IT WAS FOUND THAT THE CAUSE OF THIS FAILURE WAS ATTRIBUTED TO AN ERROR IN THE MANUFACTURER NUMBER AND A LACK OF CLEAR GUIDANCE FOR VERIFYING SUCCESSFUL SUBMISSION IN THE ORGANIZATION'S PROCEDURES. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED CORRECTING THE MANUFACTURER NUMBER IN THE ORGANIZATION'S PROCEDURES AND DEFINING THE STEPS REQUIRED TO VERIFY SUCCESSFUL ENTRY INTO THE CDRH DATABASE. WHILE THE ORIGINAL SUBMISSION WAS ON-TIME, THIS FILING IS BEING MADE BECAUSE THE ORIGINAL SUBMISSION WAS NOT SUCCESSFULLY ENTERED INTO THE CDRH DATABASE WITHIN THE 30-DAY SUBMISSION REQUIREMENT.
DEALER REPORTS THAT WHILE THE USER WAS OUT DRIVING, THEIR CHAIR STOPPED RUNNING. HE FOUND THAT THE FUSE CABLE FOR THE BATTERIES WERE BURNT HALFWAY AND THAT THERE WAS A MELTED SPOT ON THE BATTERY LID. UPON FURTHER INSPECTION, THE DEALER STATES THAT THE BATTERY CONNECTORS WERE LOOSE AND THAT THE BURN HAPPENED BETWEEN THE BATTERY AND THE FUSE. NO INJURIES WERE REPORTED.
DEALER REPORTS THAT WHILE THE USER WAS OUT DRIVING, THEIR CHAIR STOPPED RUNNING. HE FOUND THAT THE FUSE CABLE FOR THE BATTERIES WERE BURNT HALFWAY AND THAT THERE WAS A MELTED SPOT ON THE BATTERY LID. UPON FURTHER INSPECTION, THE DEALER STATES THAT THE BATTERY CONNECTORS WERE LOOSE AND THAT THE BURN HAPPENED BETWEEN THE BATTERY AND THE FUSE. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538007 | MAGIC MOBILITY EXTREME 8 | WHEELCHAIR, POWERED | ITI | SUNRISE MEDICAL | EXTREME 8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |