DRIVE

Additional Manufacturer Narrative

INCIDENT DEVICE: OVERBED TABLE, MODEL NUMBER # 13003 SERIAL NUMBER # (B)(4). THE INVESTIGATION OF INCIDENT IS DESCRIBED AS BELOW: HOW MANY SIMILAR MDR, COMPLAINTS, OR SERVICE REQUESTS FOR THE SAME PRODUCT HAVE YOU RECEIVED OVER THE PAST THREE (3) YEARS? WE HAVE NOT RECEIVED ANY SIMILAR MDR, COMPLAINTS OR SERVICE REQUEST FOR THE SAME PRODUCT OVER THE PAST THREE YEARS. IF YOU HAVE RECEIVED REPORTS OF THE SIMILAR PROBLEM, FOR EACH CASE, WHAT WAS THE ROOT CAUSE AND CORRECTIVE ACTIONS? N/A. IS THERE A CHANGE ON THE DESIGN OF THE ITEM SINCE THEN THAT WILL REQUIRE A NEW STATIC LOAD TEST AND FATIGUE TEST. THERE IS NO CHANGES ON THE DESIGN OF THE ITEM. PLEASE PROVIDE A COPY OF THE FINAL QUALITY INSPECTION RECORD ON THIS PARTICULAR PIECE OF DEVICE BEARING S/N # (B)(4). WHAT IS THE MANUFACTURE DATE OF THIS PARTICULAR PIECE OF DEVICE? MANUFACTURE DATE: 06/30/2021.

Description of Event or Problem

WE RECEIVED THE EMAIL MEDWATCH REPORT # 2438477-2022-00032 FROM OUR CUSTOMER DRIVE DEVILBISS HEALTHCARE ON (B)(6) 2022, DRIVE EMAIL CONTENT AS BELOW: THE MEDICAL DEVICE INVOLVED IN THE INCIDENT IS A OVERBED TABLE, MODEL NUMBER # 13003. THE SERIAL NUMBER IS (B)(4). PLEASE REFER TO THE MEDWATCH REPORT FOR INFORMATION ABOUT THE EVENT. AS OF TODAY, THE PRODUCT IN QUESTION HAS NOT BEEN RETURNED TO DRIVE MEDICAL FOR EVALUATION. DRIVE ATTACHMENT CONTENT AS BELOW: ON (B)(6) 2022, DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OVERBED TABLE. THE END USER REPORTED AS FOLLOWS: "TABLE SPRING SPRUNG CAUSING TABLE TO FLY UP WITH GREAT FORCE. STUCK HIGH NOW. VERY DANGEROUS." THE END USER DID NOT SUSTAIN ANY INJURY. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT. AS THE MANUFACTURER, JUMAO REPLIED AS BELOW: DRIVE MEDWATCH REPORT #2438477-2022-00032, INCIDENT DEVICE: OVERBED TABLE, MODEL NUMBER # 13003, SERIAL NUMBER # (B)(4), THE INVESTIGATION OF INCIDENT IS DESCRIBED AS BELOW: HOW MANY SIMILAR MDR, COMPLAINTS, OR SERVICE REQUESTS FOR THE SAME PRODUCT HAVE YOU RECEIVED OVER THE PAST THREE (3) YEARS? WE HAVE NOT RECEIVED ANY SIMILAR MDR, COMPLAINTS OR SERVICE REQUEST FOR THE SAME PRODUCT OVER THE PAST THREE YEARS. IF YOU HAVE RECEIVED REPORTS OF THE SIMILAR PROBLEM, FOR EACH CASE, WHAT WAS THE ROOT CAUSE AND CORRECTIVE ACTIONS? N/A.  IS THERE A CHANGE ON THE DESIGN OF THE ITEM SINCE THEN THAT WILL REQUIRE A NEW STATIC LOAD TEST AND FATIGUE TEST. THERE IS NO CHANGES ON THE DESIGN OF THE ITEM. THE STATIC LOAD TEST AND FATIGUE TEST REPORTS ARE SHOWN IN THE ATTACHMENT. PLEASE PROVIDE A COPY OF THE FINAL QUALITY INSPECTION RECORD ON THIS PARTICULAR PIECE OF DEVICE BEARING S/N # (B)(4). AS ATTACHED. LASTLY, WHAT IS THE MANUFACTURE DATE OF THIS PARTICULAR PIECE OF DEVICE? MANUFACTURE DATE: 06/30/2021.