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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Charge (1085)

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

Event Date 04/11/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator was not showing a full battery charge.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator was not showing a full battery charge.The customer reported that the battery continuously flashes, and the cooling fan pulsates while battery is charging (for several days).The power management (pm) board was replacement replaced, and battery is non-philips brand battery.The rse advised the customer, that the device was attempting to trickle charge the battery; the rse also advised the customer to replace the battery with philips brand battery.The customer was provided with the part number for a replacement battery.The investigation is ongoing.

Manufacturer Narrative

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Manufacturer Narrative

A follow up was performed with the customer, and it was reported that the device was tested with a different battery, and the issue had been resolved; however, the repair has not been completed and the device was not returned to service.The customer is waiting to receive a replacement battery.The investigation is ongoing.

Manufacturer Narrative

A philips remote service engineer (rse) determined that the issue was due to a failure related to the battery.The repair for this device cannot be conducted at this time, due to a back order status of a part (battery) needed for correction.The material ordered aligns with the recommended repair of the reported malfunction per the service manual.When all parts become available the repairs will be conducted.

• 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: 19184770
• MDR Text Key: 341082331
• Report Number: 2518422-2024-22531
• 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

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: Health Professional
• 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: 04/11/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/13/2024
• Date Device Manufactured: 09/23/2015
• 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