FDA Adverse Event Death Summary report: N

COMPANION STATIONARY UNIT

MDR report key: 1763542 · Received June 24, 2010

Report

Report Number
1763542
Event Type
Death
Date Received
June 24, 2010
Date of Event
June 10, 2010
Report Date
June 15, 2010
Manufacturer
PURITAN BENNET CORP.
Product Code
BYJ
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
IN, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

AT 1:20 PM, STAFF NURSE (B)(6) WAS IN RESIDENT (B)(6) ROOM ADMINISTERING HER MEDICATIONS VIA HER G-TUBE. NOTHING ABNORMAL WAS NOTED AT THAT TIME. (B)(6) WAS THEN CALLED OUT OF THE ROOM FOR A PHYSICIAN'S PHONE CALL. AT 1:25PM, CNA (B)(6) CHECKED ON (B)(6) AND SHE WAS COMFORTABLE AND IN NO DISTRESS. AT 1:30 PM, (B)(6) HEARD (B)(6) MOANING AND UPON ENTERING HER ROOM FOUND A VAPOR CLOUD SURROUNDING THE RESIDENT, ALONG WITH WHAT APPEARED TO BE FROZEN OXYGEN TUBING TO (B)(6) TRACHEOSTOMY. SHE IMMEDIATELY GRABBED AND REMOVED THE TUBING FROM THE RESIDENT AND YELLED FOR ASSISTANCE FROM NURSE (B)(6). (B)(6) ENTERED THE ROOM, NOTING THE SAME FINDINGS, AND IMMEDIATELY PAGED FOR NURSES "STAT" TO ROOM (B)(6). (B)(6) THEN ENTERED THE ROOM AGAIN ALONG WITH DON (B)(6) AND (B)(6). ALL PRESENT NOTED ALL TUBINGS AND FIXTURES ON THE LARGE LIQUID OXYGEN TANK TO BE FROZEN. THE NURSES IMMEDIATELY BEGAN TO ASSESS HER. A BLISTERED AREA AROUND THE TRACH STOMA. THE TRACH COLLAR AND INNER CANNULA WERE LEFT IN PLACE DUE TO CONCERN OF DISLODGING ANY ICE OR OTHER MATERIAL THAT MAY HAVE ENTERED THE CANNULA. THE RESIDENT DID NOT APPEAR TO BE IN RESPIRATORY DISTRESS AND HER OXYGEN SATURATION WAS 98% ON ROOM AIR. AN ADD'L BLISTER WAS NOTED UP THE RESIDENT'S NECK ON THE RIGHT SIDE (PER HOSPITAL STAFF). THE BLISTER AROUND THE STOMA APPEARED TO EXTEND ALSO DOWN THE RESIDENT'S CHEST, APPEARING AS ONE, LARGE INTACT BLISTER. HER LEFT THUMB AND FIRST FINGER WERE ALSO NOTED TO BE RED AND COLD, BUT NO BLISTERS WERE NOTED. ROOM AIR OXYGEN SATURATION READ 98% AND NO SIGNS OF RESPIRATORY DISTRESS WERE NOTED. VITAL SIGNS WERE STABLE. 911 WAS CALLED, AS WAS THE PHYSICIAN AND RESIDENT'S RESPONSIBLE PARTY. STAFF CONTINUED TO ASSESS THE RESIDENT FOR INJURIES AND PREPARED TO SEND THE RESIDENT OUT VIA EMERGENCY SERVICES AMBULANCE. AN ORDER WAS OBTAINED TO PLACE SILVADENE CREAM TO ANY AREAS WHERE BURNS WERE NOTED AND THIS WAS DONE. THE LIQUID OXYGEN TANK WAS REMOVED FROM THE ROOM AND TAKEN OUTSIDE OF THE FACILITY TO ENSURE THE SAFETY OF ALL RESIDENTS AND STAFF. THE RESIDENT REMAINED IN STABLE CONDITION AND WAS TRANSFERRED TO (B)(6) HOSP EMERGENCY ROOM FOR FURTHER EVAL AND TREATMENT. RESIDENT'S PHYSICIAN ASSESSED HER AT THE HOSP AND CALLED TO UPDATE THE DON, (B)(6). HE STATED THE (B)(6) CHEST X-RAY WAS NEGATIVE AND THAT THERE APPEARED TO BE NO DAMAGE TO THE LUNGS OR OTHER INTERNAL ORGANS. SHE REMAINS IN STABLE CONDITION AND WAS ADMITTED FOR TREATMENT OF 2ND DEGREE BURNS. RESIDENT (B)(6) PASSED AWAY AT (B)(6) HOSP ON THE EVENING OF (B)(6) 2010. LIFE GAS REP REMOVED THE SUSPECT TANK FROM THE FACILITY ON MONDAY, JUNE 14, 2010. (B)(4) SURVEYOR ENTERED THE FACILITY ON MONDAY, JUNE 14, 2010 TO CONDUCT A COMPLAINT INVESTIGATION, INITIATED BY THE FACILITY'S SELF-REPORTING OF THE INCIDENT. SHE EXITED THE FACILITY ON JUNE 15, 2010 AND THE COMPLAINT WAS SUBSTANTIATED WITHOUT FINDINGS. A COPY WAS PROVIDED TO MS (B)(4) AS WELL. THE FACILITY WILL CONTINUE TO PROVIDE ANY AND ALL ASSISTANCE RELATED TO FURTHER INVESTIGATION INTO THIS MATTER BY GOVERNMENT ENTITIES, AUTHORITIES OR INDEPENDENT INVESTIGATORS IN AN EFFORT TO DETERMINE THE CAUSE OF THE EQUIPMENT MALFUNCTION. IT WAS DETERMINED THAT ALL STAFF PROVIDING CARE FOLLOWED FACILITY POLICIES AND PROCEDURES AND THAT SAID POLICIES AND PROCEDURES WERE CURRENT AND CONSISTENT WITH ANY AND ALL MFR RECOMMENDATIONS AND INDUSTRY STANDARDS OF PRACTICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COMPANION STATIONARY UNIT LIQUID OXYGEN BASE UNIT BYJ PURITAN BENNET CORP. C41 0729006

Patients

Seq Age Sex Outcome Treatment
1 43 YR Death| H