MAUDE Adverse Event Report: XHALE ASSURANCE CURAPLEX; SPO2 SENSOR

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2018

Event Type  malfunction  

Event Description

A new nasal pulse oximetry reader was placed on the pt.Was getting reading that pt's spo2 was in the 80's, 10 hours later.The pt had no respiratory distress issue and there hadn't been any vent setting changes.The spo2 pleth was perfect and the hr matched the ekg hr, spo2 was reading in the 80's.As a result md was called and vetting settings were changed.Another pt who had a nasal pulse ox on and a few hours later was showing spo2 in the 80's, with a nice pleth and spo2 and ekg hr matching.After suctioning and calling respiratory, we placed a finger pulse ox on the pt and realized it was the nasal pulse ox and not the pt.Ref# mw5075475.

• Brand Name: CURAPLEX
• Type of Device: SPO2 SENSOR
• Manufacturer (Section D): XHALE ASSURANCE
• MDR Report Key: 7292893
• MDR Text Key: 101061895
• Report Number: MW5075474
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR