MAUDE Adverse Event Report: RESMED LIMITED CPAP H5I HUMIDIFIER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 36901

Device Problems Loss of Power (1475); Output Problem (3005)

Patient Problem Respiratory Distress (2045)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

The resmed vpap auto unit stopped working while in use.The rn called rt because the patient was complaining that he could not breathe with the nasal mask on due to lack of pressure.The rn removed the mask from the patient.Rt went to troubleshoot unit (removed the mask to check air flow).The mask was placed on the patient, and after three minutes the unit started cooling down and eventually shut off.

• Brand Name: CPAP H5I HUMIDIFIER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LIMITED; 9001 spectrum center blvd; san diego CA 92123
• MDR Report Key: 8944324
• MDR Text Key: 155951414
• Report Number: 8944324
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/20/2019,08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 36901
• Device Lot Number: 374025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1