FDA Adverse Event Malfunction Summary report: N

RESPIRONICS

MDR report key: 17595752 · Received August 22, 2023

Report

Report Number: 2518422-2023-20398
Event Type: Malfunction
Date Received: August 22, 2023
Date of Event: August 10, 2023
Manufacturer: RESPIRONICS, INC.
Product Code: MNT
PMA / PMN Number: K102985
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: BIOMEDICAL ENGINEER
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H10: PER GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED 08/30/2023, THE BIOMEDICAL (BIOMED) ENGINEER CONFIRMED THAT A 1124 ¿BATTERY FAILED¿ ERROR OCCURRED AND VERIFIED THAT THE ISSUE WAS RESOLVED ONCE THE FAULTY BATTERY WAS REPLACED. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED.

Description of Event or Problem · 0

PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60, INDICATING THAT THE BATTERY THAT WAS PURCHASED DID NOT WORK, AND A BATTERY FAILURE ALARM ERROR MESSAGE WAS DISPLAYED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER REPORTED TO THE REMOTE SERVICE ENGINEER (RSE) THAT THE BATTERY THAT WAS PURCHASED DID NOT WORK, AND A BATTERY FAILURE ALARM ERROR MESSAGE WAS DISPLAYED-- THE CUSTOMER IS NOW WANTING TO GET CONFIRMATION ON THE CORRECT BATTERY FOR THE VENTILATOR. THE RSE PROVIDED THE CUSTOMER WITH THE PART NUMBER AND PRICE OF THE REPLACEMENT INTERNAL BATTERY FOR REPAIR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
44927	RESPIRONICS	VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE	MNT	RESPIRONICS, INC.	V60 V60PLUS VENTILATOR

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown