MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE CANN OXYMIZER PENDANT; CONSERVER, OXYGEN

Model Number P-224

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

No membrane in pendant.Nurse got a new oxymizer from same supply that was safe and able to be used.This was a near miss-did not reach the patient.

• Brand Name: CANN OXYMIZER PENDANT
• Type of Device: CONSERVER, OXYGEN
• Manufacturer (Section D): DRIVE DEVILBISS HEALTHCARE; 99 seaview blvd; port washington NY 11050
• MDR Report Key: 12158121
• MDR Text Key: 261227669
• Report Number: 12158121
• Device Sequence Number: 1
• Product Code: NFB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P-224
• Device Catalogue Number: P-224
• Device Lot Number: 10 210493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1