MAUDE Adverse Event Report: OHIO MEDICAL, LLC OHIO MEDICAL; FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Deliver (2338)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/29/2021

Event Type  malfunction  

Event Description

Patient was at home on bipap (bilevel positive airway pressure) machine with standard settings for o2.The patient had desaturation to 70's, and respiratory therapist put patient on hospital machine.Upon review, it was determined that the o2 flow meter was showing 15lpm, despite no o2 flowing being delivered.Manufacturer response for flowmeter, (brand not provided) (per site reporter): they are investigating.

• Brand Name: OHIO MEDICAL
• Type of Device: FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE
• Manufacturer (Section D): OHIO MEDICAL, LLC; 1111 lakeside dr; gurnee IL 60031
• MDR Report Key: 11677538
• MDR Text Key: 245807477
• Report Number: 11677538
• Device Sequence Number: 1
• Product Code: CCN
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24090 DA