MAUDE Adverse Event Report: RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 V60PLUS VENTILATOR

Device Problems Failure to Charge (1085); Failure to Run on Battery (1466)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

E1: reporting institution phone: (b)(6).Reporter phone: (b)(6).

Event Description

Philips received a complaint from the customer on the v60 indicating that there was a problem with the battery.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no harm to the patient or user.The investigation is ongoing.

Manufacturer Narrative

H10: the customer called technical support to report that the battery was defective and not holding a charge.A service proposal for a replacement battery was sent to the customer for approval, and the customer accepted.A field service engineer (fse) was dispatched onsite to evaluate and repair the device.Upon arrival, the fse confirmed the reported issue, replaced the faulty battery, and verified that the issue was resolved.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.

Manufacturer Narrative

H10: per good faith effort (gfe) response received 07feb2024, the field service engineer (fse) confirmed that the device was not in patient use at the time the issue was discovered.The fse also stated that the defective battery, whose battery lot code was m91807-p1, was in fact less than 5 years old based on the date of manufacturing, and the battery replacement was part of standard preventive maintenance.The replacement of the battery is aligned to the periodic maintenance procedure specified in the v60 service manual which indicates that the battery requires replacement every 5 years to ensure proper system performance.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: V60 V60PLUS VENTILATOR
• 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: 18159414
• MDR Text Key: 328397309
• Report Number: 2518422-2023-30905
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2024
• Date Device Manufactured: 10/05/2020
• 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