FDA Adverse Event Injury Summary report: N

SENSORMEDICS 3100A

MDR report key: 3010705 · Received March 13, 2013

Report

Report Number
MW5029377
Event Type
Injury
Date Received
March 13, 2013
Date of Event
March 10, 2013
Report Date
March 13, 2013
Manufacturer
SENSORMEDICS
Product Code
LSZ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
RESPIRATORY THERAPIST

Narratives

Description of Event or Problem · 1

(B)(6) HOSPITAL, (B)(6): FAILURE OF: SENSORMEDICS 3100A DESIGNATED AS COVENANT #3FL, BIOMED #(B)(4). ON (B)(6) 2013, I WAS THE ASSIGNED NIGHT SHIFT CHARGE THERAPIST FOR RESPIRATORY CARE. APPROX 0400 ON MARCH 11, I WAS INFORMED BY THE NICU THERAPIST THAT AT ABOUT 1900 ON THE (B)(6) THE SENSORMEDICS 3100A, ON A BABY AT THE TIME, SUDDENLY STOPPED WORKING AND FAILED JUST AS 2 NURSES WALKED INTO THE ROOM TO ASSESS THE BABY. APPARENTLY THE NURSES CALLED THE RESPIRATORY THERAPIST AND THE OSCILLATOR WAS UNABLE TO BE RECOVERED AND HAD TO BE CHANGED OUT WHILE THE BABY WAS BEING VENTILATED WITH AN AMBU BAG. WHEN I WAS INFORMED THE OSCILLATOR HAD BEEN STRIPPED, CLEANED AND THE CIRCUIT DISPOSED OF, APPARENTLY, RIGHT AFTER THE INCIDENT MANY HOURS EARLIER. IT IS UNCERTAIN WHAT OR IF ANYTHING FAILED AT THE TIME DUE TO: THE OSCILLATOR BEING TAKEN OFF AND CLEANED. THE CIRCUIT BEING TAKEN OFF AND DISPOSED OF - THE TRASH HAD BEEN EMPTIED AND THE CIRCUIT WAS LONG GONE BY THE TIME I WAS INFORMED. THE SERENDIPITOUS NATURE OF THE HFOV FAILING JUST WHEN THE 2 NURSES WALKED IN THE ROOM. IT SHOULD BE NOTED THAT THERE IS, FOR THE NICU, A POLICY THAT SAYS THAT THE NURSES CAN PUT AN OSCILLATOR ON STANDBY TO SUCTION A BABY ON THEIR OWN WITHOUT HAVING THE RESPIRATORY THERAPIST PRESENT. IT SHOULD ALSO BE NOTED THAT NOWHERE IN THEIR TRAINING ARE ANY COMPETENCIES DONE TO INSURE THEY KNOW HOW TO RECOVER AN OSCILLATOR THAT IS FAILING TO RESTART AFTER BEING PUT ON STANDBY FOR SUCTIONING. PER THE RESPIRATORY THERAPIST WHO TOOK THE REPORT, A "INCIDENT REPORT RL SOLUTION REPORT WAS MADE. PER NEW POLICY RISK MANAGEMENT HAS TO BE INFORMED OF ANY EQUIPMENT ISSUES AND THEN ONLY RISK MANAGEMENT WILL MAKE THE DETERMINATION IF THE EQUIPMENT HAS TO BE CHECKED BY BIOMEDICAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
106358 SENSORMEDICS 3100A HFOV HIGH FREQUENCY OSCILLATORY VENTILATOR LSZ SENSORMEDICS UNK

Patients

Seq Age Sex Outcome Treatment
1