FDA Adverse Event Malfunction Summary report: N

V60 VENTILATOR

MDR report key: 8836689 · Received July 29, 2019

Report

Report Number: 2031642-2019-05145
Event Type: Malfunction
Date Received: July 29, 2019
Report Date: June 5, 2018
Manufacturer: RESPIRONICS CALIFORNIA, INC
Product Code: MNT
PMA / PMN Number: K082660
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ADDED: REPORT SOURCE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative · 1

DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 29JULY2019. THE PRODUCT SUPPORT ENGINEER (PSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE PSE ADVISE THE CUSTOMER THAT EITHER THE LED IS ON AND THE VOLTAGE SIGNAL FROM THE POWER MANAGEMENT (PW) CONTROLLER IS LESS THAN 1.0 VOLT OR GREATER THAN 2.5VOLT OR THE LED IS OFF AND THE VOLTAGE IS GREATER THAN OR EQUAL TO 0.5V. THE CUSTOMER ADVISED THE CUSTOMER TO REPLACED THE POWER SWITCH OVERLAY, USER INTERFACE (UI) TO POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD (PCB) CABLE, PM PCB ONLY IF LED IS FUNCTIONING. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE VENTILATOR ALARM LIGHT EMITTING DIODE (LED) FAILED. IT WAS REPORTED THAT THE VENTILATOR WAS IN CLINICAL USE AT THE TIME OF THE EVENT OCCURRED. THERE WAS NO PATIENT HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
633643	V60 VENTILATOR	VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE	MNT	RESPIRONICS CALIFORNIA, INC	V60

Patients

Seq	Age	Sex	Outcome	Treatment
1