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

Model Number V60

Device Problem No Audible Alarm (1019)

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

Event Date 07/09/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the service engineer, reporting that the v60 ventilator displayed error code 1102 (primary alarm failure).There was no patient involvement when the issue occurred.No patient or user harm reported.A philips field service engineer (fse) reported that during evaluation of the device, the v60 ventilator displayed error code 1102 (primary alarm failure).The se replaced the speaker (#2) to resolve the issue.This concludes the investigation.

Manufacturer Narrative

The suspected part was returned to philips for failure investigation.The technician documented the following conclusion/root cause, "the product investigation lab (pil) has verified by a temporary install of the faulty speaker onto the pil standard test bed (stb) that the error code e1102 repeats during the diagnostic portion of the stb operation.In addition the pil tech verified that the speaker does not operate as expected during an alarm condition.This is due to an open voice coil on the speaker.".

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17397975
• MDR Text Key: 320133357
• Report Number: 2518422-2023-16990
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2023
• Initial Date FDA Received: 07/26/2023
• Date Device Manufactured: 02/15/2017
• 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