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

Model Number	1830-7-50
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lack of adhesive to secure the mask properly would prevent the patient from receiving proper oxygen levels during delivery.This could cause the patient to desaturate or become hypoxic.
Event or Problem Description
Adhesive on mask not secured properly.
Event or Problem Description
Adhesive on mask not secured properly.
Additional Manufacturer Narrative
The lack of adhesive to secure the mask properly would prevent the patient from receiving proper oxygen levels during delivery.This could cause the patient to desaturate or become hypoxic.The complaint was confirmed with the customer's photo.Reviewed complaint history for the 24 months preceding the complaint reporting date.Inspected inventory of this part and found no non-conformances.Reviewed the dhr and found no anomalies or causes for nc.(b)(4).Sent resolution to the customer.

• 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 ledge, MI 49544 ; 6162598415
• MDR Report Key: 16216434
• Report Number: 3000219639-2023-00002
• Device Sequence Number: 7518436
• Product Code: BYG
• UDI-Device Identifier: 10607411800419
• UDI-Public: 10607411800419
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: Health Professional
• Device Model Number: 1830-7-50
• Device Catalogue Number: 1830-7-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/02/2023
• 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