MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; MASK,TRACHEOSTOMY,ADULT

Catalog Number HCS245EH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/28/2022

Event Type  Injury  

Event Description

According to the customer, the tracheostomy mask has a 'nozzle piece that does not go in all the way causing the oxygen to leak'.The customer reported that it came apart when she was sleeping causing her to become 'unresponsive'.The customer stated her family called the ambulance and she was taken to the emergency room where she was supplied oxygen and sent home.

Manufacturer Narrative

According to the customer, the tracheostomy mask has a 'nozzle piece that does not go in all the way causing the oxygen to leak'.The customer reported that it came apart when she was sleeping causing her to become 'unresponsive'.The customer stated her family called the ambulance and she was taken to the emergency room where she was supplied oxygen and sent home.The sample is available but has not been returned for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: MASK,TRACHEOSTOMY,ADULT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15635924
• MDR Text Key: 302061600
• Report Number: 1417592-2022-00198
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2022

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 Catalogue Number: HCS245EH
• Device Lot Number: 74921110003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female