FDA Adverse Event Injury Summary report: N

VOCSN

MDR report key: 11616390 · Received April 5, 2021

Report

Report Number: 3013095415-2021-00011
Event Type: Injury
Date Received: April 5, 2021
Date of Event: February 4, 2021
Report Date: April 5, 2021
Manufacturer: VENTEC LIFE SYSTEMS, INC
Product Code: CBK
PMA / PMN Number: K162877
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

H6: THE DEVICE WAS RETURNED TO VENTEC FOR AN INVESTIGATION. IT WAS OBSERVED THAT THERE WAS A LEAK IN THE O2 ACCUMULATOR, AND THAT THE DEVICE HAD ALARMED AS SPECIFIED. THE USER MANUAL STATES: WARNING: THE INTERNAL O2 CONCENTRATOR IS NOT INTENDED FOR LIFE SUPPORT. WHERE THE PRESCRIBING HEALTHCARE PROFESSIONAL HAS DETERMINED THAT AN INTERRUPTION IN THE SUPPLY OF OXYGEN, FOR ANY REASON, MAY HAVE SERIOUS CONSEQUENCES TO THE USER, AN ALTERNATE SOURCE OF OXYGEN SHOULD BE AVAILABLE FOR IMMEDIATE USE. THE CUSTOMER STATED THAT THE PATIENT QUICKLY SATURATED AFTER BEING SWITCHED TO THEIR BACKUP DEVICE. THE PATIENT IS FINE AND THERE WAS NO ADVERSE OUTCOME.

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT YET BEEN RETURNED TO VENTEC FOR AN EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT'S BLOOD OXYGEN LEVEL BECAME DESATURATED WHILE USING A VENTILATOR. THE VENTILATOR APPEARED TO BE FUNCTIONING NORMALLY; HOWEVER, THE PATIENT WAS PLACED ON A BACK-UP VENTILATOR AND THE PATIENT'S BLOOD OXYGEN LEVELS RETURNED WITHOUT HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
510446	VOCSN	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	VENTEC LIFE SYSTEMS, INC	PRT-00490-001

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention