FDA Adverse Event Malfunction Summary report: N

BELLAVISTA

MDR report key: 12478230 · Received September 15, 2021

Report

Report Number: 3004553423-2021-01196
Event Type: Malfunction
Date Received: September 15, 2021
Date of Event: August 13, 2021
Report Date: August 18, 2021
Manufacturer: IMTMEDICAL AG
Product Code: CBK
UDI-DI: 07640149380019
PMA / PMN Number: K163127
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, DURING ANALYSIS OF LOGFILES IT SHOWS CFB LOGGING IS VISIBLE FROM (DEVICE TIME) 13/08/2021 11:25:34 TILL 13/08/2021 11:31:43. ITS VISIBLE AS PER THE LOG ENTRY "VENT STATE-1" THE VENTILATION IS RUNNING, WITH THE LAST SETTING TILL THE UNIT TURNED OFF AT 13/08/2021 11:31:43. NURSE CALL IS ACTIVE, RED ALARM LIGHTS WERE ON AND THE BUZZER IS ACTIVE. THE UNIT START TO WORK NORMALLY AFTER THE NEXT RESTART AT 31/03/2021 12:04:58. INSTALLED SOFTWARE VERSION IS (B)(4) PRIOR TO CFB LOGGING "INTERNAL O2 SENSOR THREAD SAMPLER" ERROR LOG MESSAGE IS VISIBLE AT 13/08/2021 11:25:27. AS A RESOLUTION SOFTWARE BUG IN IMPROVED INTERNAL O2 SENSOR COMMUNICATION HANDLING FOUND IN (B)(4). THIS ISSUE IS RESOLVED WITH (B)(4). VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT BELLAVISTA 1000 SCREEN SHOWED "BELLAVISTA DETECTED A USER INTERFACE ISSUE". THE NURSE CONFIRMED THAT THE VENTILATION CONTINUES AND NO PATIENT HARM REPORTED FROM THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1373836	BELLAVISTA	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	IMTMEDICAL AG	BELLAVISTA 1000		07640149380019

Patients

Seq	Age	Sex	Outcome	Treatment
1