FDA Adverse Event Injury Summary report: N

SEN SATEC

MDR report key: 768105 · Received October 4, 2006

Report

Report Number
MW1040610
Event Type
Injury
Date Received
October 4, 2006
Manufacturer
A F TECHNOLOGIES, INC.
Product Code
KMI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AT 0730 THE CHARGE NURSE WAS CALLED TO THE RESIDENT ROOM TO ASSESS A FALL. UPON ENTERING THE ROOM THE CHARGE NURSE OBSERVED RESIDENT SITTING ON THE FLOOR SURROUNDED BY URINE LEANING TO THE RESIDENT'S LEFT. RN ASSESSED AND NOTED THAT RESIDENT WAS UNABLE TO FLEX AND EXTEND RIGHT LEG AND COMPLAINED OF PAIN IN RIGHT HIP. PHYSICIAN AND FAMILY NOTIFIED. ORDERS RECEIVED TO TRANSFER RESIDENT TO HOSPITAL. FOLLOW-UP 10/03/06; 1. NO NEW ALARMS HAVE BEEN USED. THIS SEEMS TO BE AN ISOLATED CASE OF A MALFUNCTIONING 180 DAY BED ALARM. WE HAVE NOT ORDERED IN 180 DAY BED ALARMS. WE HAVE ONLY ORDERED IN 90 DAY BED ALARMS. AT THIS POINT WE HAVE NOT FOUND ANY OTHER 180 DAY BED ALARMS. THE 90 DAY PAD WAS SEEN TO WORK IN THE SAME SIMULATED SITUATION THAT THE 180 DAY DID NOT CONSISTENTLY WORK. CNAS CHECK THE ALARMS EVERY SHIFT TO ENSURE PROPER FUNCTIONING. AS FAR AS THE TRANSITION TO THE SHEETS FOR USE OVER THE BED ALARMS, THE RN SUPERVISOR AUDITED, NOTIFIED STAFF AND CHANGED THE NURSING CARE INSTRUCTIONS SHEETS. AFTER TALK WITH BED ALARM COMPANY THEY FURTHER RECOMMENDED TRIALING A NEW POSITION UNDER THE SHOULDER BLADES FOR THESE RESIDENTS WHO ELEVATE THEIR BEDS AND USE A BED PAD. CHARGE NURSE CALLED HOSPITAL AND RECEIVED VERBAL REPORT THAT THERE WAS A RIGHT HIP FRACTURE. RESIDENT IS ASSIST OF ONE WHILE USING WALKER. RESIDENT HAS BED ALARM ORDERED ON CARE PLAN. BED ALARM WAS ON BED BUT DID NOT SOUND. RESIDENT DID NOT UTILIZE CALL LIGHT. NURSING STAFF WERE ALERTED FROM RESIDENT CALLING FOR HELP. RESIDENT IS NORMALLY CONTINENT ACCORDING TO THE MDS OF SEPT. 5, 2006. UPON INVESTIGATION, NURSING STAFF FOUND THAT THE BED ALARM DID NOT SOUND DUE TO THE BED POSITION. HISTORY OF RESIDENT POSITIONING NOTED BY STAFF IS THAT THE RESIDENT PREFERS HEAD AND FEET ELEVATED. THE BED WAS FOUND WITH HEAD AND FEET RAISED. RESIDENT WILL BE REASSESSED FOR INTERVENTIONS UPON RETURN FROM HOSPITAL. THERAPY WILL SCREEN UPON RETURN. ALL OTHER RESIDENTS IN FACILITY WILL BE ASSESSED FOR SLEEPING POSITIONS IN COMBINATION WITH USE OR ALARMS. UPDATE 09292006: 1. STAFF TO KEEP CALL BELL AND NEEDED ITEMS WITHIN REACH - KEEP ROOM WELL LIT AND CLUTTER FREE - ASSIST OF 1 REQUIRED FOR TRANSFERS - ENSURE RESIDENT IS WEARING PROPER FOOTWEAR FOR TRANSFERS - TOILET Q 2 HOURS AND UPON NEED/REQUEST - STAFF TO CLEAN AND PROVIDE EYEGLASSES DAILY - ENCOURAGE RESIDENT TO USE CALL BELL FOR ASSISTANCE AND TO WAIT FOR ASSISTANCE - FOOT PEDALS REMOVED FROM WHEELCHAIR - REMIND RESIDENT TO REQUEST ASSISTANCE WITH TRANSFERS AND TO WALK FOR ASSISTANCE - ENCOURAGE RESIDENT TO USE WALKER WHEN AMBULATING - MONITOR PULSEOX - APPLY BED ALARM TO RESIDENT'S BED - APPLY ANTI-ROLLBACK DEVICE TO WHEELCHAIR - STAFF TO USE WHEELCHAIR FROM TRANSPORTING RESIDENT TO/FROM SHOWER ROOM - CHAIR ALARM TO WHEEL CHAIR - DO NOT LEAVE UNATTENDED IN BATHROOM 2. THE INTERVENTIONS WERE ALL IN PLACE AS FURTHER INTERPRETED ON THE NURSING CARE INSTRUCTION SHEETS. 3. THE RESIDENT HAD BEEN TAKEN TO THE BATHROOM IN THE EARLY MORNING AT APPROXIMATELY 3AM, 4. RESIDENT WAS ASKED WHAT HAPPENED. 5. RESIDENT HAS HISTORY OF NOT USING CALL BELL. 6. CALL BELL WAS FOUND TO BE FUNCTIONING. UPDATE 09/293006 1905 HOURS: RESIDENT HAS HISTORY OF FALLS, 2. RESIDENT IS NOT ON TOILETING SCHEDULE BECAUSE RESIDENT HAD BEEN ASSESSED AS CONTINENT. 3. FROM THE INVESTIGATION WE NOW ALSO HAVE ANOTHER THEORY THAT THE BED ALARM DID NOT ACTIVATE DUE TO THE BED PAD BEING OVER THE BED ALARM. THIS THEORY EVOLVED FROM RETESTING THE DEVICE, WHICH DID NOT IMMEDIATELY ACTIVATE UPON A STAFF MEMBER GETTING UP FROM THE DEVICE WITH THE BED PAD REMAINING. IN REGARDS TO OTHER RESIDENTS THAT HAVE THEIR BED TOTALLY ELEVATED AT FOOT AND HEAD, THE FACILITY HAS FOUND NO OTHERS. IN REGARDS TO RESIDENTS WHO HAD A BED PAD ON TOP OF THE ALARM FACILITY FOUND OTHERS. FACILITY DECIDED TO REMOVE THE HEAVIER BED PAD AND USE A SHEET INSTEAD OF BED PAD TO REDUCE THE WEIGHT APPLIED TO BED ALARM. ALARM DID PROVE TO SOUND WHEN JUST A SHEET WAS OVER THE BED ALARM. ADMINISTRATION IS CURRENTLY REVIEWING OTHER PRODUCTS TO TRIAL. ADMINISTRATION IS ALSO REVIEWING THE INCIDENT WITH MANUFACTURER AS A POSSIBLE FAULTY PRODUCT. THE POSSIBLE FAULTY BED ALARM HAS BEEN REMOVED TO SEND TO MANUFACTURER FOR INSPECTION AFTER CONFERENCE CALL WITH MANUFACTURER ON TUESDAY. 4. RESIDENT WAS FOUND SITTING ON BUTTOCKS ON FLOOR AT FOOT OF BED. UPDATE 10/02/2006: 1. THE RESIDENT LAST FALL WAS 1/1/2006. THE RESIDENT HAD STOOD UP FROM WHEELCHAIR AND FELL. 2. RESIDENT STATED I SLIPPED AND FELL. 3. THE RESIDENT EXHIBITS MODIFIED INDEPENDENCE WITH DECISION MAKING AND HAS SHORT TERM MEMORY LOSS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SEN SATEC BED PAD -180 DAY KMI A F TECHNOLOGIES, INC. 260 *

Patients

Seq Age Sex Outcome Treatment
1 * Hospitalization| R| S