MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Charging Problem (2892)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that the battery was not charging.The device was reported to be in use at the time of the reported problem.The customer reported that there was no adverse outcome.The remote service engineer (rse) was informed by the customer that the device did not work on ac power and only worked on battery.The device did not show the battery charging and no yellow power leds were illuminated when plugged in.The customer attempted to use a different ac outlet and power cord, but the problem persisted.It was verified that there was no voltage at the power supply while also showing 116v coming in at the ac filter.Battery voltage showed as 15v dc.The customer was advised to replace the power supply and was provided with part information.This investigation is ongoing.

Manufacturer Narrative

H10: the customer confirmed in a good faith effort (gfe) response received on 12/08/2022, that the recommended replacement power supply was ordered and resolved the reported issue.The customer does not plan to return the faulty parts and declined to provide patient information.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 15949575
• MDR Text Key: 307880895
• Report Number: 2031642-2022-03079
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1