FDA Adverse Event Death Summary report: N

Q-STARIV

MDR report key: 180110 · Received July 29, 1998

Report

Report Number
180110
Event Type
Death
Date Received
July 29, 1998
Date of Event
July 1, 1998
Report Date
July 15, 1998
Manufacturer
MEDLINE INDUSTRIES, INC,
Product Code
KMI
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MN, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ON 7/1/1998, AT 02:35A.M. RN, WAS CALLED TO PTS ROOM BY NURSE'S AIDE. DURING ROUTINE NIGHT SHIFT ROUNDS AIDE FOUND PT SITTING ON THE FLOOR AT THE BEDSIDE. HER HEAD AND NECK WERE CAUGHT IN THE 1/2 SIDE RAIL. AIDE IMMEDIATELY CALLED RN FOR ASSISTANCE. RN INDICATED TO RPTR THAT AIDE HAD NOT REMOVED PT BEFORE IMMEDIATELY CALLING RN TO THE ROOM. AT 2:39A.M. THE DIRECTOR OF NURSING WAS CALLED AND AT 02:44A.M. THE ADMINISTRATOR WAS CALLED. BOTH ARRIVED AT THE FACILITY BY 03:15A.M. PT WAS A "FULL CODE" RESIDENT. RN CHECKED FOR A CAROTID PULSE AND FOUND NONE. RN INDICATED SHE COULD NOT FULLY CHECK THE RESIDENT'S VITALS IN POSITION SHE WAS IN SO SHE AND AIDE DISLODGED RESIDENT FROM RAIL, AND LAID HER ON FLOOR. RN CHECKED ALL VITALS, INCLUDING PULSE, BLOOD PRESSURE AND PUPIL RESPONSE. RN INDICATED TO RPTR THAT PUPILS WERE FIXED AND DILATED, THERE WERE NO VISIBLE SIGNS OF LIFE AND RESUSCITATION WOULD HAVE BEEN FUTILE. RN CALLED ANOTHER NURSE, TO THE FLOOR STAT TO CONFIRM CHECK OF VITALS. HE VERIFIED THAT THERE WERE NO VISIBLE SIGNS OF LIFE AND CORONER'S OFFICE WAS CALLED. THE RESIDENT WORE "WANDERGUARD" TABS STRING TYPE MONITOR. RN #1 STATED THE TABS MONITOR BOX WAS ATTACHED TO HEADBOARD BY APPROPRIATE VELCRO TAPE. SHE INDICATED THAT STRING WAS CLIPPED TO RESIDENT'S GOWN IN APPROPRIATE LOCATION. STRING WAS NOT PULLED SUFFICIENT LENGTH TO TRIGGER ALARM. RN #1 DESCRIBED STRING AS "TAUT" AND OBSERVED THAT HAD STRING PULLED ANOTHER INCH ALARM WOULD HAVE SOUNDED. RN #1 DID NOT OBSERVE ANY BROKEN EQUIPMENT OR EQUIPMENT IN DISREPAIR. SHE STATED TO RPTR THAT MATTRESS HAD NOT APPEARED TO HAVE MOVED FROM ITS PROPER LOCATION, AND THAT IF IT HAD BEEN ASKEW SHE WOULD HAVE NOTICED THAT. SHE INDICATED THE RESIDENT'S BEDSHEETS WERE NOT WRAPPED AROUND THE RESIDENT'S NECK, THAT SHE OBSERVED NO RIPS OR TEARS IN THE MATTRESS AND THAT RAIL WAS NOT BROKEN. RN #1 INDICATED THAT RESIDENT'S HEAD AND NECK WERE BETWEEN RAIL AND MATTRESS, AND THAT IT WAS DIFFICULT TO DISENGAGE RESIDENT'S HEAD AND NECK BECAUSE IT WAS SO TIGHT. AFTER RESIDENT WAS PLACED ON FLOOR, RN #1 NOTICED THAT HER FEET HAD STARTED TO MOTTLE. NIGHT OF DEATH, FACILITY WAS ADEQUATELY STAFFED, HAVING RN AND TWO AIDES FOR THIRTY-SIX CLIENTS ON UNIT. PT'S BED WAS PURCHASED BY FACILITY IN EITHER 1993 OR 1994 AND IS MFG BY JOERNS CO. IT MOVES TO "LOW" POSITION OF 13 1/2 INCHES AND RN CONFIRMS IT WAS IN LOW POSITION NIGHT OF PT'S DEATH. RAIL WAS SHORT SIDE RAIL ALSO MADE BY JOERNS CO. LOCKING AND ATTACHMENT SYSTEM OF JOERNS RAIL IS INDEPENDENT FROM OTHER RAILS. SHORT SIDE RAIL EXHIBITED NO UNDUE BOWING WHEN EXAMINED AFTER DEATH. MATTRESS WAS COMPATIBLE WITH BED. FACILITY DOES NOT PURCHASE USED OR REFURBISHED MATTRESSES, AND STRUCTURAL INTEGRITY OF MATTRESS WAS SOUND AFTER ACCIDENT. WITH EACH TABS MOBILITY MONITOR 30 INCH CORD IS PROVIDED FOR MONITORING CLIENTS IN BED. FACILITY DID NOT MODIFY OR CHANGE LENGTH OF THIS CORD.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 Q-STARIV MATTRESS KMI MEDLINE INDUSTRIES, INC, MDT 237880A NA
2 TABS MOBILITY MONITOR KMI WANDERGUARD, INC. 25000 NI
3 JOERNS FREESTYLE BED FNJ JOERNS HEALTHCARE, INC. B40 BED/7140 SIDERAIL *

Patients

Seq Age Sex Outcome Treatment
1 80 YR Death JOERNS FREESTYLE BED & HALF SIDERAIL, WANDERGUARD| TABS MOBILITY MONITOR 12/1/1997 - 7/1/1998