MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 21jan2021.

Event Description

It was reported to philips that the speaker is not passing testing and the customer requested remote support.The device was not in use at the time of the event.This issue occurred while testing.The device was evaluated by the customer (biomed) with assistance from a philips remote service engineer (rse).The biomed stated that the speaker is not passing and has a non resettable alarm.The biomed stated when it powers up the alarm sounds, but is a different tone.The biomed found error code 5021 (speaker test) and 1102 (primary alarm failed) in the significant event log.The rse advised the customer to verify that the mc speaker is connected, and also verify that the braded wire is not touching the speaker can.The rse instructed the biomed to verify 8 ohms to the speaker, and if necessary to replace the speaker.Replacement part information for a speaker assembly was provided to the customer if replacement was required.A good faith effort was made and the biomed confirmed that replacement of the speakers resolved the issue.The device was tested as per the philips service manual, and was returned to service.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 11211064
• MDR Text Key: 229115450
• Report Number: 2031642-2021-00271
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2009
• 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