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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Shut Off (2939)

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

Event Date 02/03/2024

Event Type  malfunction  

Event Description

Philips received a complaint from customer reporting the v60 ventilator could not be shut down.The device was not in clinical use.There was no report of harm.There was no patient or user impact reported.The device did not meet specification for intended use and was removed from service for maintenance.Investigation is ongoing.

Manufacturer Narrative

E: (b)(6) hospital.(b)(6).Phone: reporter- (b)(6).

Manufacturer Narrative

H10: a philips authorized service provider (asp) reported the issue was resolved by the customer with replacement of the motor control (mc) printed circuit board assembly (pcba).The device was verified as operational and returned to service after repairs were completed.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: christine cox ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18654081
• MDR Text Key: 334697144
• Report Number: 2518422-2024-05952
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/22/2024
• Date Device Manufactured: 11/05/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1