MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1028772

Device Problem Power Problem (3010)

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

Event Date 06/23/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the bi-pap indicating that the device shut off when it is unplugged.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm reported to the patient or user.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.Device evaluation and repair are pending.Investigation is ongoing.

Manufacturer Narrative

The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse stated that they were told that the device was not stored properly.The fse stated that they sought the opinion of others and that, together, they determined that the device was more than likely not stored properly.Furthermore, it is probable that the device was stored plugged in, with the power switch turned on which depleted the internal battery over time.Multiple attempts have been made to try to obtain further information about this case but no response received from the customer.This file is closed and can be reopened if new information becomes available.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 17351638
• MDR Text Key: 319430827
• Report Number: 2518422-2023-16183
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• 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: 1028772
• Device Catalogue Number: 1028772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• 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