FDA Adverse Event Death Summary report: N

PHILIPS RECALL OF SELECT V60 RESPIRONICS VENTILATORS

MDR report key: 13782800 · Received March 15, 2022

Report

Report Number
MW5108169
Event Type
Death
Date Received
March 15, 2022
Report Date
October 24, 2021
Manufacturer
RESPIRONICS CALIFORNIA, LLC
Product Code
MNT
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2021 MY WIFE (B)(6) WAS A PATIENT AT (B)(6) HOSPITAL LOCATED ON THE 4TH FLOOR OF (B)(6) HOSPITAL, (B)(6). SHE BEGAN HAVING BREATHING PROBLEMS. I ASKED THE DUTY NURSE TO TRANSFER HER TO THE ER LOCATED NEXT DOOR OR TO THE ICU LOCATED ON THE 7TH FLOOR. I WAS TOLD THAT BECAUSE SHE WAS IN A CRITICAL UNIT THEY DID NOT TRANSFER PATIENTS FROM ONE CRITICAL CARE UNIT TO ANOTHER . I ASKED TO SEE THE HOSPITALIST ON DUTY. SHE CAME AND DIRECTED MY WIFE TO HAVE X-RAYS. FROM MYCHART I READ THAT MY WIFE HAD BACTERIAL AND ASPIRATION PNEUMONIA. SHE WAS IMMEDIATELY PLACED ON ANTIBIOTICS AND GIVEN ATIVAN FOR PAIN. ON SUNDAY MORNING (B)(6) HER BREATHING PROBLEMS WORSEN. DR. (B)(6) RECOMMENDED THAT I MAKE MY WIFE COMFORTABLE BY PLACING HER ON A VENTILATOR. SHE WAS IMMEDIATELY PLACED ON A PHILIPS V60 RESPIRONICS VENTILATOR. FOR A BRIEF TIME SHE SEEMED TO BE BREATHING FINE. AS THE EVENING AND NIGHT APPROACH HER BREATHING AGAIN WAS DIFFICULT. THE DUTY RESPIRATORY TECHS MADE ADJUSTMENT S TO THE OXYGEN BY INCREASING IT AS THEY THOUGHT WAS APPROPRIATE. DR. (B)(6) SUGGESTED SHE BE GIVEN MORPHINE TO HELP HER PAIN. I WAS SITTING AT HER BEDSIDE HOLDING HER ARM AND HALF ASLEEP WHEN I WOKE UP TO THE MALE RESPIRATORY TECHS MAKING AN ADJUSTMENT TO THE VENTILATOR. THAT WAS APPROXIMATELY 3 AM. HE DID NOT SAY A WORD TO ME JUST TOUCHED MY SHOULDERS AND WALKED OUT. APPROXIMATELY 30 MINUTES LATER THE VENTILATORS MADE A LOUD BUZZING NOISE AND I CHECK MY WIFE AND SHE WAS NO LONGER BREATHING. I IMMEDIATELY ASK THE FEMALE WHAT DID THAT GUY DO, SHE INFORMED ME THAT HE HAD TURNED THE OXYGEN DOWN. I ASK WHY DID HE DO THAT WHEN HE KNEW SHE NEEDED THAT OXYGEN. NO ANSWER WAS GIVEN . EARLIER IN THE EVENING I HAD ASKED THE FEMALE RESPIRATORY TECH WHY WAS MY WIFE PLACED ON A VENTILATOR THAT HAD BEEN RECALLED. SHE TOLD ME THE LOWER PART SHOWN ON THE ENCLOSED PHOTO WAS THE RECALLED PART AND IT WAS NOT BEING USED. MY REQUEST OF THE FDA IS THE PHILIPS V60 RESPIRONICS VENTILATOR SHOWN USED ON MY WIFE A RECALLED UNIT? IF SO, MY WIFE PASSED FROM IT'S USE AT THE HANDS OF (B)(6) HOSPITAL DOCTORS AND RESPIRATORY TECHS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
525561 PHILIPS RECALL OF SELECT V60 RESPIRONICS VENTILATORS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60

Patients

Seq Age Sex Outcome Treatment
1 Unknown Death