MAUDE Adverse Event Report: NOX MEDICAL NOX RIP BELT; RESPIRATORY EFFORT SENSOR

Model Number NOX RIP BELT DISPOSABLE, LARGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

The device used for the home sleep test was discarded after the study and therefore not available for analysis.The device manufacturing production documentation was reviewed and showed that the product lots passed all incoming, in-process and release testing with no failures or need for re-work.Should additional information become available, this report will be updated.

Event Description

The patient described that they developed contact dermatitis on the arms after undergoing a home sleep study with the device which required administration of oral steroids to treat the rash.

• Brand Name: NOX RIP BELT
• Type of Device: RESPIRATORY EFFORT SENSOR
• Manufacturer (Section D): NOX MEDICAL; katrínartúni 2; reykjavik, 105 ; IC 105
• Manufacturer (Section G): NOX MEDICAL; katrínartúni 2; reykjavik, 105 ; IC 105
• Manufacturer Contact: bryce whited ; katrínartúni 2; reykjavik, 105 ; IC 105
• MDR Report Key: 10275118
• MDR Text Key: 198855034
• Report Number: 3007389703-2020-00003
• Device Sequence Number: 1
• Product Code: MNR
• UDI-Device Identifier: 15694311110187
• UDI-Public: 15694311110187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NOX RIP BELT DISPOSABLE, LARGE
• Device Catalogue Number: 551040
• Device Lot Number: 190304
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other