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

Model Number 8130-7

Device Problems Material Separation (1562); Improper Flow or Infusion (2954); Patient Device Interaction Problem (4001)

Patient Problem Confusion/ Disorientation (2553)

Event Date 11/13/2022

Event Type  malfunction  

Event Description

Patient (pt) w/ covid was being treated w/ high flow o2 via nc (nasal cannula) at 40l, while she also had the non-rebreather mask on at 100%.The pt was confused and frequently pulling on the bag connected to the non-rebreather mask.The pt¿s daughter brought to staff¿s attention that bag had become separated from mask.The bag is connected to the mask w/ tape that is applied by the manufacturer.The icu nurse manager stated that sometimes the tape is not applied evenly on the mask and bag.He was not sure if that was the case in this event.

• Brand Name: OXYGEN MASK (ADULT) HIGH CONCENTRATION NON-REBREATHER
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): SALTER LABS; 2710 northridge drive nw,; suite a; grand rapids MI 49544
• MDR Report Key: 16077207
• MDR Text Key: 306418830
• Report Number: 16077207
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2022

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: Other
• Device Model Number: 8130-7
• Device Catalogue Number: 8130-7
• Device Lot Number: 220103
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Race: White