FDA Adverse Event Injury Summary report: N

QUANTUM RXE

MDR report key: 174092 · Received June 18, 1998

Report

Report Number
MW4002277
Event Type
Injury
Date Received
June 18, 1998
Date of Event
April 28, 1998
Report Date
June 3, 1998
Manufacturer
HEALTHDYNE TECHNOLOGIES INC.
Product Code
CBK
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
KS, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

A 58 YR OLD MAN, DIED ON 4/28/98. PT HAD ANYOTROPHIC LATERAL SCLEROSIS BUT RPTR BELIEVES THE VENTILATORS HE HAD BEEN ON CONTRIBUTED TO HIS DEATH. ON 4/8/98, DR PRESCRIBED A QUANTUM PRESSURE SUPPORT VENTILATOR FOR USE IN PT'S HOME, AS THE DR SPECULATED HE WOULD ONLY LIVE FOR SEVERAL MORE DAYS. THE VENTILATOR SUSTAINED PT WITH NO ILL EFFECTS UNTIL SATURDAY, 4/25/98, AT WHICH TIME THE ALARM WAS SOUNDING AND THE VENTILATOR SHOWED A SYS ALERT ON THE READOUT. THE VENTILATOR SHUT DOWN, COMPLETELY, SPOUSE CONTACTED HOME CARE AGENCY, WHO PROVIDED THE VENTILATOR, AND WAS INSTRUCTED TO TURN THE VENTILATOR OFF THEN BACK ON AND THE ALARM SHOULD GO OFF. SHE DID AS SHE WAS INSTRUCTED BUT THE ALARM WOULD NOT GO OFF AND THE VENTILATOR WAS STILL INOPERABLE. CONTACT TOLD SPOUSE HE WAS NOT FAMILIAR WITH THE VENTILATOR AND HE WOULD NEED TO SPEAK WITH HIS SUPERVISOR. HE INSTRUCTED SPOUSE TO MOVE THE VENTILATOR AWAY FROM THE WALL ONE FOOT BECAUSE THE ORIGINAL RESPIRATORY THERAPIST WHO SET IT UP DID SO INCORRECTLY CAUSING THE VENTILATOR TO OVERHEAT. AFTER THE VENTILATOR COOLED DOWN, IT WAS SUPPOSED TO BE ABLE TO BE OPERABLE AGAIN. AFTER 1 1/2 HRS, THE VENTILATOR CAME BACK ON. DURING THE TIME THE VENTILATOR WAS DOWN, PARAMEDICS HAD BEEN CONTACTED AND PUT AN OXYGEN MASK ON PT TO ASSIST HIS BREATHING. SPOUSE WAS INSTRUCTED BY HOME HEALTH AGENCY TO CONTACT AGENCY ON MONDAY, 4/27/98, TO ASK FOR A NEW VENTILATOR. WHEN SPOUSE CONTACTED AGENCY ON 4/27/98, HE TOLD HER SHE COULD NOT HAVE ONE BECAUSE HE FELT IT WAS THE WRONG VENTILATOR FOR HER HUSBAND AND THAT HE HAD TO NOTIFY THE CASE WORKER WITH FACILITY TO ORDER A DIFFERENT VENTILATOR. IN THE MEANTIME, THE VENTILATOR MALFUNCTIONED AGAIN ON THE NIGHT OF 4/27/98. THIS TIME, THE AIR WAS GOING OFF AND ON AND THE ALARM WAS CONSTANT. THE READOUT ON THE VENTILATOR WAS AGAIN SHOWING A SYS ALERT. SPOUSE ATTEMPTED TO CONTACT AGENCY NUMEROUS TIMES THAT NIGHT AND PARAMEDICS WERE CALLED AS WELL TO ADMINISTER OXYGEN. THE ORIGINAL RESPIRATORY THERAPIST WHO HAD INITIALLY SET UP THE VENTILATOR ARRIVED 2 1/2 HRS LATER WITH A SECOND VENTILATOR (SERIAL NUMBER UNK AT THIS TIME). BY THAT TIME PT'S OXYGEN LEVEL DROPPED FROM 92% TO 41%. HE THEN WENT INTO A DEEP SLEEP FROM LACK OF OXYGEN AND THE SECOND VENTILATOR WAS OF NO BENEFIT. PT WAS RUSHED TO THE HOSP IN AN ATTEMPT TO BRING UP HIS OXYGEN LEVEL. WHEN THAT DID NOT HELP, HE WAS SENT BACK HOME AND PLACED BACK ON THE VENTILATOR. HE PASSED AWAY ON TUESDAY, 4/28/98, AND THE ALARM ON THE VENTILATOR DID NOT SOUND TO INDICATE HE WAS NO LONGER BREATHING. SPOUSE STATED HOME CARE AGENCY WANTED TO PICK UP THE SECOND VENTILATOR BUT SHE DID NOT WANT TO GIVE IT TO THEM UNTIL SHE WAS SURE THIS INCIDENT HAD BEEN REPORTED TO THE PROPER AUTHORITIES. SHE HAD THE VENTILATOR PLACED IN A DIFFERENT LOCATION UNTIL SHE COULD MAKE THAT DETERMINATION. INVESTIGATOR REQUESTED SHE PROVIDE THE SERIAL NUMBER OF THE VENTILATOR AND SHE STATED SHE WOULD OBTAIN IT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 QUANTUM RXE PRESSURE SUPORT VENTILATOR CBK HEALTHDYNE TECHNOLOGIES INC. NI NA
2 QUANTUM RXE PRESSURE SUPPORT VENTILATOR CBK HEALTHDYNE TECHNOLOGIES INC. NI NA

Patients

Seq Age Sex Outcome Treatment
1 58 YR