MAUDE Adverse Event Report: SALTER LABS SALTER LAB 8150 PERCENT - O2 - LOCK MASK; VENTIMASK

Model Number 8150

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 01/10/2018

Event Type  Injury  

Event Description

Snf reported to oncall rt that when they connect sal 8150 venti mask sett at 35 percent/ 6 lpmflow on 10 lpn melloniumconcentrator drop from set 6 to 4 lpm.Rt had them try 12 different concentrators and multiple 81505, 3 in total with no end.Resident switched to different venturi mask device from different manufacturer that didn't cause in liter flow and delivered prescribed fio2 percent.Dose or amount: o2 @ 6 lpm, frequency: continuous, route: ventitimask.Dates of use: (b)(6) 2018.Diagnosis or reason for use: copd.

• Brand Name: SALTER LAB 8150 PERCENT - O2 - LOCK MASK
• Type of Device: VENTIMASK
• Manufacturer (Section D): SALTER LABS; 100 west sycamore rd.; arvin CA 93203
• MDR Report Key: 7263321
• MDR Text Key: 99930390
• Report Number: MW5075180
• 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: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 01/30/2018

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: Health Professional
• Device Model Number: 8150
• Device Lot Number: (10)011915 (10)N0P070317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 40