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

Model Number V60

Device Problem Power Problem (3010)

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

Event Date 04/17/2024

Event Type  malfunction  

Manufacturer Narrative

G: phone: (b)(4).

Event Description

Philips received a complaint by the customer on the v60 indicating that the alarm for internal battery failure had occurred.It was reported there was no patient involvement at the time the issue was discovered.It was reported that the alarm for internal battery failure had occurred.The remote service engineer (rse) and customer performed a troubleshoot by installing a known good philips brand battery and confirmed the unit cycled normally.An alarm for running on internal battery then occurred.It was verified the alternating current (ac) power was connected, the power light emitting diode (led) was not illuminated on the power switch overlay, the ac out was functional, and the power cord measured 120 volts alternating current (vac).The customer then called back and informed the rse that there was no voltage on the power supply.The rse advised the customer to order and replace the power supply.The customer replaced the power supply to resolve the reported issue.The device passed required performance verification tests per philips standards 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.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19197270
• MDR Text Key: 341239079
• Report Number: 2518422-2024-22957
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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
• Reporter Occupation: Biomedical Engineer
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/26/2024
• Date Device Manufactured: 12/16/2016
• 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