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

Model Number V60

Device Problems Display Difficult to Read (1181); No Display/Image (1183)

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

H10: g: contact information (b)(6).

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that after the device was powered on, the display was initially dim but brightened up over the course of several minutes.It was reported that there was no patient involvement at the time the issue was discovered as the issue occurred during preventive maintenance (pm) service.The biomedical engineer (bme) called technical support to report that after the device was powered on, the display was initially dim but brightened up over the course of several minutes.The remote service engineer (rse) discussed options for upgrading to the second-generation liquid crystal display (lcd) with the bme and provided the bme with the part identification (id) for upgrading by bit and piece versus replacing the first-generation user interface (ui) printed circuit board assembly (pcba) with the second-generation ui pcba.The rse also provided the bme with the part id of the user interface (ui) printed circuit board assembly (pcba) without navigation ring for repair.This investigation is ongoing.

Manufacturer Narrative

H10: per good faith effort (gfe) response received 04apr2024, the biomedical engineer (bme) opted for the complete display assembly instead of all the individual parts.The device passed the 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.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.

• 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: 19066928
• MDR Text Key: 339647223
• Report Number: 2518422-2024-18111
• 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,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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/11/2024
• Date Device Manufactured: 05/26/2010
• 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