FDA Adverse Event Injury Summary report: N

LTV 1150

MDR report key: 3647230 · Received February 21, 2014

Report

Report Number
MW5034712
Event Type
Injury
Date Received
February 21, 2014
Date of Event
January 27, 2014
Report Date
February 20, 2014
Manufacturer
PULMONICS
Product Code
CBK
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

HERE IS THE ACCOUNT OF WHAT HAPPENED ON (B)(6) 2014. UPON THE NEED TO DELIVER A MANUAL BREATH TO (B)(6), THE MANUAL BREATH BUTTON WAS PRESSED AND HELD TO SUPPLY A SUFFICIENT AMOUNT OF AIR VIA THE VENTILATOR. THEN (B)(6) VENTILATOR SWITCHED TO SIMV/CPAP MODE ON ITS OWN. AT WHICH POINT I NOTED THAT THE VENT READING HAD AN ERROR MESSAGE THAT INDICATED THAT A SPONTANEOUS BREATH TRAIL HAD BEGUN AND THAT THE PT HAD FAILED IT. THEN I HIT THE RESET BUTTON TO NO AVAIL. THEN I IMMEDIATELY SHUT THE VENT DOWN AND TURNED IT BACK ON. AT THIS POINT, (B)(6) WAS IN DISTRESS. (B)(6) MOM WAS IN THE ROOM DURING THE EVENT. THIS WAS THE THIRD EVENT THAT THE ERROR READING HAD BEEN NOTED, ONE THAT EVOLVED INTO A TRIP TO THE EMERGENCY ROOM. AT THIS TIME, NO MEDICAL PERSONNEL INCLUDING THE PT'S DME COMPANY COULD TELL THE PT'S NURSES WHAT THE CAUSE OF THE ERROR WAS. THIS CREATED FEAR IN AND LACK OF CONFIDENCE IN THE VENTILATOR/OPERATOR OF A PT WITH RESPIRATORY FAILURE. THE EMERGENT CARE TEAM AT THE HOSPITAL COULDN'T FIND A PROBLEM WITH THE VENT EVEN AFTER THE RESPIRATORY TEAM RESEARCHED THIS PRODUCT. WE WERE SENT HOME WITH NEW VENTS AND TOLD IT WAS THE NURSE AND OUR FAMILY THAT HAD TO HAVE GONE INTO THE INTERNAL SETTINGS. AFTER CONTINUING ON OUR OWN TO RESEARCH THE VENT PROBLEMS FOUND A STUDY THAT INDICATED A SOFTWARE UPDATE AT WHICH TIME THE PT'S FAMILY CONTACTED THE MFR AND WAS PLACED IN CONTACT WITH TECHNICIAN THAT INFORMED US OF THE NEW UPDATE THAT HAD A SHORTCUT TO A TEST THAT CAN ONLY BE PERFORMED IN THE PRESENCE OF AN RESPIRATORY THERAPIST. CONTINUOUS USE OF THE LTV 1150 VENTILATOR DUE TO ACUTE RESPIRATORY FAILURE OVER THE PAST 4 YRS. DATES OF USE: (B)(6) 2014.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
109716 LTV 1150 LTV 1150 CBK PULMONICS

Patients

Seq Age Sex Outcome Treatment
1 25 YR Hospitalization| L| O| R