FDA Adverse Event Malfunction Summary report: N

RESPIRONICS

MDR report key: 24931914 · Received April 20, 2026

Report

Report Number: 2518422-2026-112422
Event Type: Malfunction
Date Received: April 20, 2026
Date of Event: April 13, 2026
Report Date: April 24, 2026
Manufacturer: RESPIRONICS, INC.
Product Code: MNT
UDI-DI: 00884838025776
PMA / PMN Number: K102985
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

A GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED ON 21APR2026 FROM THE AUTHORIZED SERVICE PROVIDER (ASP) STATED THAT THE EVENT WAS CAUSED BY A "TECHNICAL ISSUE," AND THAT THE DEVICE WAS OPERATING AS EXPECTED. NO FURTHER INFORMATION ON THE "TECHNICAL ISSUE" WAS PROVIDED, SO AN ADDITIONAL GFE WAS SENT REQUESTING CLARIFICATION. AN ADDITIONAL GFE RESPONSE RECEIVED ON 23APR2026 AGAIN STATED "IT IS TECHNICAL CONSULTING ISSUE" AND THAT NO REPAIR WAS INVOLVED FOR THE V60. IT IS CONCLUDED, BASED ON THE GFE RESPONSES, THAT THE DEVICE WAS OPERATING AS EXPECTED AND THERE WAS A TECHNICAL ISSUE SOMEWHERE ELSE IN THE AIR SUPPLY CIRCUIT. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

Additional Manufacturer Narrative · 0

(B)(6).

Description of Event or Problem · 0

PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS LOW AIR SUPPLY PRESSURE OBSERVED. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THIS INVESTIGATION IS ONGOING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
168353	RESPIRONICS	VENTILATOR, CONTINUOUS USE, MINIMAL VENTILATORY SUPPORT, FACILITY USE	MNT	RESPIRONICS, INC.	V60		00884838025776

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown