FDA Adverse Event Malfunction Summary report: N

LTV 1200 VENTILATOR

MDR report key: 18120107 · Received November 13, 2023

Report

Report Number: 2021710-2023-18391
Event Type: Malfunction
Date Received: November 13, 2023
Date of Event: October 16, 2023
Report Date: November 13, 2023
Manufacturer: VYAIRE MEDICAL, INC
Product Code: CBK
UDI-DI: 00845873002696
PMA / PMN Number: K083688
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 0

D4: CORRECTED MODEL#, G4: PMA/510K. THE SUPPLEMENTAL REPORT HAS CORRECTED MODEL# TO 18888-201 AND PMA/510K TO K083688.

Description of Event or Problem · 0

THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1200 VENTILATOR. THE MAGNETIC RESONANCE-CONDITIONAL VENTILATOR SHIPPED WITH A MAGNETIC CABLE SUPPORT BRACKET ON THE PORTABLE BACKUP BATTERY UNIT. THERE IS NO INDICATION ON THE BRACKET, BATTERY, VENTILATOR, PRODUCT PACKAGING, OR OTHERWISE THAT THE MR CONDITIONAL EQUIPMENT CONTAINED THE MAGNETIC BRACKET. THE BRACKET, ALONG WITH THE VENTILATOR WHICH WAS IN-USE ON A PATIENT WAS PULLED INTO THE MRI (MAGNETIC RESONANCE IMAGING) MACHINE'S BORE OPENING. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2238879	LTV 1200 VENTILATOR	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	VYAIRE MEDICAL, INC	18888-201		00845873002696

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown