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

Model Number V60

Device Problem Temperature Problem (3022)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the device's data acquisition (da) board burned up, would like to send in for bench repair.It was reported there was no patient involvement at the time the issue was discovered.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The customer states that after replacing the da board for a second time the da board started smoking and turned unit off.Customer is requesting bench repair.The rse explained bench process and emailed the customer bench request form.The investigation on going.

Manufacturer Narrative

Bench repair evaluated the device and confirmed the da pcba was burnt.Mc pcba damaged the da pcba.Bench repair will order the motor controller pcba and data acquisition pcba.Additionally, bench repair will order the pm kit and box.Since the unit cannot be further tested in the current condition, a second estimate may be required if performance verification testing fails.

Manufacturer Narrative

The repair for this unit cannot be conducted at this time due to the part(s) being on backorder.The material has already been requested and an order for the part(s) was placed to conduct the repair of this unit.The material ordered motor controller pcba and data acquisition pcba aligns with the recommended repair of the alleged malfunction per the service manual.When the parts become available the repairs will be conducted.If new information is received and suggests that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

Manufacturer Narrative

The removed motor control printed circuit board assembly (pcba) was returned to the product investigation lab (pi).The pil technician installed the motor control pcba into a pi ventilator to duplicate the reported issue.Visual inspection of the motor control pcba visual inspection noted no anomalies.Pil failed to confirm the allegation of the motor control pcba burned up the data acquisition pcba.No error, diagnostic code, or failure was observed in suspect pca.

• 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: 16552393
• MDR Text Key: 311396683
• Report Number: 2518422-2023-07013
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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: Health Professional
• 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: 02/17/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/14/2023; 07/18/2023; 05/13/2024
• Supplement Dates FDA Received: 03/31/2023; 07/19/2023; 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2018
• 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