FDA Adverse Event Injury Summary report: N

INFINITY EXPANDABLE HI-LOW HOME CARE BED

MDR report key: 20923672 · Received December 13, 2024

Report

Report Number
MW5163579
Event Type
Injury
Date Received
December 13, 2024
Date of Event
December 9, 2024
Report Date
December 12, 2024
Manufacturer
EMERALD SUPPLY
Product Code
FNL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2024, THE STRYKER BED MY MOTHER HAD BEEN IN FOR 10 MONTHS, WAS REPLACED BY A COMPLETELY DIFFERENT KIND OF BED ¿ ONE PURCHASED BY THE FACILITY AS COMPONENT PARTS; THE FRAME FROM ONE MANUFACTURER, THE ELECTRONICS FROM ANOTHER. THE BED FRAME HAS A LABEL ON IT THAT SAYS INFINITY MODEL #: 54000. THE ELECTRONIC COMPONENTS WERE MADE BY A COMPANY NAMED (B)(4). THIS BED PROVIDES ABSOLUTELY NO SECURITY AT ALL FOR MY MOTHER WHO SUFFERS TWO NEUROMUSCULAR DISEASES. I EXPRESSED CONCERN IMMEDIATELY THAT THERE WAS NO HEAD OR FOOT ON THIS REPLACEMENT BED, NO GUARD RAILS THAT SHE WAS ACCUSTOMED TO USING TO HELP WITH HER MOBILITY AND SECURITY, AND THAT THE AIR MATTRESS WAS EXTREMELY SLIPPERY. THE PT/OTS AND CNAS WHO CARE FOR HER EXPRESSED CONCERN THAT THIS BED WAS NOT SAFE FOR MY MOTHER WITH HER CONDITIONS. THESE CONCERNS WERE IGNORED BY THE FACILITY¿S ASSISTANT ADMINISTRATOR (B)(6). ON SATURDAY, (B)(6) 2024, THREE DAYS AFTER THE NEW BED WAS INSTALLED, AT APPROXIMATELY 7 AM, I RECEIVED A PHONE CALL THAT MY MOTHER HAD FALLEN OFF OF THE BED. I SPOKE WITH THE FLOOR NURSE AT THAT TIME AND ASKED HER WHAT HAPPENED. SHE TOLD ME THAT THE CNA WAS CHANGING MY MOTHER, LEFT THE ROOM TO GET ANOTHER CNA TO HELP HER, AND WHEN SHE RETURNED, MY MOTHER HAD FALLEN OFF THE BED. I ASKED HOW LONG THE CNA WAS OUT OF THE ROOM, AND WAS TOLD 15 MINUTES. I QUESTIONED WHY MY MOTHER WAS LEFT ALONE IN A PRECARIOUS POSITION UNATTENDED, BUT SHE HAD NO ANSWER FOR ME. WHEN I ARRIVED AT THE FACILITY SHORTLY AFTER I SPOKE TO THE NURSE, AND SAW THE CONDITION THAT MY MOTHER WAS IN, TOOK HER TO THE EMERGENCY ROOM AT (B)(6) HOSPITAL BECAUSE THE (B)(6) DID NOT HAVE ANYONE FROM THE FACILITY AVAILABLE. THE INCIDENT WAS REPORTED TO THE NURSING DEPARTMENT BY STAFF. WHEN I SPOKE TO THE NURSING OFFICE THE FOLLOWING MONDAY, I NOTICED THAT THE STORY CHANGED SIGNIFICANTLY FROM WHAT THE FLOOR NURSE TOLD ME IMMEDIATELY FOLLOWING THE FALL. I RESEARCHED THE RULING ON BED SAFETY IN LONG TERM CARE/NURSING HOME FACILITIES ON THE FDA WEBSITE AND FOUND THAT BED RAILS WERE ALLOWED UNDER CERTAIN CONDITIONS, WHICH WERE MET. LETTERS WERE SUBMITTED BY MY MOTHER¿S DOCTOR AND HER PHYSICAL THERAPIST ORDERING BEDRAILS AND THE FACILITY IS TO DATE, STILL REFUSING TO COMPLY WITH THE REGULATIONS. THE SOCIAL WORKER ASSIGNED TO MY MOTHER¿S FLOOR AND THE PHYSICAL THERAPY DEPARTMENT HAVE BOTH CONFIRMED THIS.

Description of Event or Problem · 0

ADDITIONAL INFORMATION RECEIVED ON 12/12/2024 FOR REPORT MW5163579. I AM INCLUDING A FEW ADDITIONAL PHOTOS TO MY COMPLAINT (CASE NUMBER (B)(4)). THE FIRST TWO PHOTOGRAPHS WILL SHOW CLEARLY HOW MY MOTHER HAS SLIPPED TO THE BOTTOM OF THE BED AND HAS NO FOOT TO STOP HER FROM GOING OFF THE BOTTOM. THESE INADEQUATE BEDRAILS OFFER NO SAFETY AND ARE NOT USEFUL FOR HER TO HOLD IN ORDER TO HELP HERSELF. THE BED RAILS ARE NEITHER TALL ENOUGH NOR LONG ENOUGH FOR MY MOTHER TO REACH THEM. EVEN WHEN PROPERLY PLACED ON THE BED, SHE WOULD HAVE TO REACH OVER HER HEAD AND DOWN THE SIDE OF THE BED TO GRIP THEM. THAT ACTION ALONE COULD CAUSE HER TO ROLL OFF THE BED. THE OTHER PHOTOS SHOW THE OLD STRIKER BED WHICH PROVIDED HER WITH SAFETY AND A MEANS TO HELP HERSELF.

Description of Event or Problem · 0

ADDITIONAL INFORMATION RECEIVED ON 12/20/2024 FOR REPORT MW5163579 TO UPDATE MANUFACTURER NAME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1804996 INFINITY EXPANDABLE HI-LOW HOME CARE BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL EMERALD SUPPLY 54000

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown