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

Model Number V60 V60PLUS VENTILATOR

Device Problem Material Integrity Problem (2978)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that the caster on the cart was not working properly.It was reported that there was no patient involvement at the time the issue was discovered.The customer reported to the remote service engineer (rse) that the caster on the cart was not working properly, and the rse provided the customer with the part number of the replacement locking caster for repair.

Manufacturer Narrative

Per gfe (good faith effort) response, the customer confirmed that the replacement caster was ordered and replaced and verified that the reported issue was resolved.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

Manufacturer Narrative

Per gfe (good faith effort) response, the customer confirmed that the replacement caster has been ordered and received and will be replaced once the device is available for repair.The customer also stated that the ventilator was not removed from service since the caster does not impact the performance of the device.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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17048626
• MDR Text Key: 316388800
• Report Number: 2518422-2023-12687
• Device Sequence Number: 1
• Product Code: MNT
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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 Operator: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/06/2023; 07/14/2023
• Supplement Dates FDA Received: 06/12/2023; 07/20/2023
• Date Device Manufactured: 12/10/2015
• 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