MAUDE Adverse Event Report: RESPIRONICS, INC. HEATED HUMIDIFIER DC ASSY; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1051158

Device Problems Electrical /Electronic Property Problem (1198); Material Split, Cut or Torn (4008)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation that a user's power cord is damaged with exposed wire and sparking.There was no patient harm or injury reported.Labeling instructs the user to periodically inspect the ac power cord for signs of wear or damage and to replace the ac power cord if worn or damaged.The manufacturer has not received the devices for investigation.Despite multiple requests, no device has been returned.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

• Brand Name: HEATED HUMIDIFIER DC ASSY
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13948833
• MDR Text Key: 288176673
• Report Number: 2518422-2022-12007
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1051158
• Device Catalogue Number: 1051158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male