FDA Adverse Event Malfunction Summary report: N

V60 VENTILATOR

MDR report key: 10093864 · Received May 27, 2020

Report

Report Number: 2031642-2020-01867
Event Type: Malfunction
Date Received: May 27, 2020
Report Date: April 30, 2020
Manufacturer: RESPIRONICS CALIFORNIA, INC
Product Code: MNT
PMA / PMN Number: K082660
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

G4: 24JUN2020. B4: 26JUN2020. THE CUSTOMER CONFIRMED ALARM LIGHT EMITTING DIODE (LED) DIAGNOSTIC ERROR; THEY NOTED THE (LED) IS WORKING. THE REMOTE SERVICE ENGINEER ADVISED THE CUSTOMER IF LED IS WORKING TO REPLACE THE PRINTED CIRCUIT BOARD ASSEMBLY POWER MANAGEMENT (PCBA,PWR MGMT) PER THE SERVICE MANUAL. THE CUSTOMER REPLACED THE POWER SWITCH OVERLAY AND THE (PCBA,PWR MGMT) TO RESOLVE THE REPORTED ISSUE. THE UNIT WAS TESTED, AND IT RETURNED TO SERVICE. 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) 2020. DATE OF REPORT: 27MAY2020.

Description of Event or Problem · 1

THE CUSTOMER REPORTED POST LED FAILURE ALARM. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
554304	V60 VENTILATOR	VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE	MNT	RESPIRONICS CALIFORNIA, INC	V60

Patients

Seq	Age	Sex	Outcome	Treatment
1