DIRECT SUPPLY

Description of Event or Problem

CASE (B)(4), ON 10/27/2023 10:11AM, WE RECEIVED AN EMAIL STATING, AT 9:30 AM ON (B)(6) 2023, (B)(6) CALLED TO REPORT AN INCIDENT THAT ALLEGEDLY INVOLVED THE FOLLOWING PRODUCT OR DEVICE: PIVOTING ASSIST DEVICE FOR PANACEA 3500 + PANACEA 3500 BED. (B)(6) REPORTED THAT THE FOLLOWING OCCURRED. AROUND (B)(6) 2023, A RESIDENT WAS USING THE PIVOT ASSIST, HER ARM GOT STUCK INSIDE THE ASSIST THROUGH THE MIDDLE, AND GRAVITY PULLED HER FEET OUT OF THE BED WHILE SHE WAS ROLLING OVER. THE RESIDENT WAS FOUND WITH HER ARM STUCK, HANGING FROM THE BED, UNABLE TO MOVE OR REMOVE HER ARM FROM THE ASSIST. THE RESIDENT BROKE HER ARM, ABOVE THE ELBOW ON THE RIGHT SIDE (DOMINANT ARM), AND SOON AFTER THE BROKEN ARM THE RESIDENT PASSED AWAY. (B)(6) SAID THAT AT THE TIME OF THE INCIDENT, THERE WERE NO OTHER PEOPLE PRESENT. THEY REQUESTED A COVER FOR THE OPENING. WE DO NOT HAVE A COVER BUT OFFERED A ZERO OPENING ASSIST THAT DID NOT HAVE ANY OPENINGS. WE REQUESTED MORE INFORMATION ABOUT THE PATIENT AND THE INCIDENT AS WELL FOR REPORTING INCLUDING PATIENT NUMBER OR INITIALS, AGE, SEX, GENDER, WEIGHT, ETHNICITY AND RACE BUT IT WAS NOT PROVIDED. NO MEDICAL REPORTS, PICTURES OR VIDEO FROM THIS INCIDENT WERE PROVIDED. THE DEVICE WAS NOT RETURNED FOR INSPECTION. ATTEMPTED CONTACTS: (B)(6) 2023 SENT 2 EMAILS. (B)(6) 2023 HAVE LEFT A VOICEMAIL AND SENT ANOTHER EMAIL, HAVE SALES LOOKING INTO IT. (B)(6) 2023 LEFT A VOICEMAIL AND SENT ANOTHER EMAIL, SALES IN CONTACT AS WELL. ON 11/16/2023 THE DESCRIPTION OF THE INCIDENT CHANGED TO THE PATIENT PUT HER ARM THROUGH THE UPPER PORTION OF THE ENABLER AND THEN FELL CAUSING THE UPPER ARM TO BREAK. WE HAVE LITTLE INFORMATION FOR THIS REPORT. WE ARE REPORTING WHAT IS REASONABLY KNOWN OUT OF AN ABUNDANCE OF CAUTION. ASSIST IS SOLD AS PART OF A BED PACKAGE. THIS REPORT IS ENTERED AFTER THE 30 DAY TIMELINE DUE TO CONFUSION REGARDING THE REPORTING OF MDRS WITH LIMITED INFORMATION.

Additional Manufacturer Narrative

WE OFFERED THE CUSTOMER A ZERO OPENING ASSIST SO THERE WOULD BE NO ISSUE WITH THE ARM GOING THROUGH THE OPENING. THE CUSTOMER REQUESTED A COVER. WE RESEARCHED A COVER BUT WERE NOT SUCCESSFUL IN FINDING ONE IN A TIMELY MANNER FOR THE CUSTOMER. THE DESCRIPTION OF THE INCIDENT CHANGED AND THE CUSTOMER OFFERED LITTLE INFORMATION REGARDING THE INCIDENT. WE TRIED TO REINACT THE INCIDENT BASED OFF THE DESCRIPTION BUT COULD NOT DETERMINE HOW THE PERSON WOULD HAVE GOTTEN THEIR ARM STUCK AND BROKE. THE CUSTOMER WAS SENT A ZERO OPENING ASSIST TO TRY AND DID PREFER IT. WE WORKED ON A DESIGN CHANGE AND THE MANUFACTURER SENT A DESIGN CHANGE BUT THE HOLES WERE STILL TOO LARGE. WE ALSO WORKED ON DESIGNING A DIFFERENT ASSIST. ADDITIONAL WARNINGS WERE ADDED TO THE SERVICE MANUAL. THE SERVICE MANUAL ALREADY HAD WARNINGS INCLUDING "AN OPTIMAL BED SYSTEM ASSESMENT SHOULD BE CONDUCTED ON EACH RESIDENT BY A QUALIFIED CLINICIAN OR MEDICAL PROVIDER TO ENSURE MAXIMUM SAFETY OF THE RESIDENT." AT THE TIME OF THE INCIDENT, (B)(4) HAD BEEN SOLD WITHOUT ANY COMPLAINTS REGARDING LIMBS GOING THROUGH THE OPENING.