MAUDE Adverse Event Report: SALTER LABS SALTER LABS; MASK, ADULT, OXYGEN, HIGH CONCENTRATION, NON-REBREATHING

Model Number	8130-7
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	11/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient could become hypoxia when the mask is not properly secured to the bag.Ifu recommends not using vapetherm with the non-rebreathers.Even though the use of heated vapetherm and flow rate was above the recommendations on the ifu, the bag was not working properly which could cause hypoxia.In addition, the mask is being used out of scope.Not supposed to be used with heated humidifiers only cool, and higher than recommended flow rates.
Event or Problem Description
Bag became separated from the mask.
Additional Manufacturer Narrative
The patient could become hypoxia when the mask is not properly secured to the bag.Ifu recommends not using vapetherm with the non-rebreathers.Even though the use of heated vapetherm and flow rate was above the recommendations on the ifu, the bag was not working properly which could cause hypoxia.In addition, the mask is being used out of scope.Not supposed to be used with heated humidifiers only cool, and higher than recommended flow rates complaint not confirmed due to lack of photo or return.Reviewed complaint history for 24 months preceding the event reporting and no trending issue was found.Reviewed dhr and found no concerns for defects.Per the email, root cause was the patient pulling the mask down and disconnecting the bag, due to confusion.Performed risk analysis and severity rating found to be 7/10.
Event or Problem Description
Bag became separated from the mask.

• Brand Name: SALTER LABS
• Common Device Name: MASK, ADULT, OXYGEN, HIGH CONCENTRATION, NON-REBREATHING
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 16256565
• Report Number: 3000219639-2023-00003
• Device Sequence Number: 17461047
• Product Code: BYG
• UDI-Device Identifier: 00607411800412
• UDI-Public: 00607411800412
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 8130-7
• Device Catalogue Number: 8130-7
• Device Lot Number: 220103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown