MAUDE Adverse Event Report: SUNMED SALTER LABS; SM ADULT W/MAN,MASK AND PEEP

Model Number AF5140MBP

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

Rebreathing co2 can cause permissive hypercarbia.Based on the reported information the criteria for reporting an adverse event have been met.

Event Description

Resuscitation bag is retaining co2, caused patient to re-breathe exhaled co2.No other negative impact.

Manufacturer Narrative

Rebreathing co2 can cause permissive hypercarbia.Based on the reported information the criteria for reporting an adverse event have been met.Complaint of backwards leak was confirmed during the investigation.Further testing shows that all resuscitation bags, with and without manometer, meet the iso standards.Updates to the instructions for use will be routed through the change control process, which is outlined in sunmed's quality management system.

Event Description

Resuscitation bag is retaining co2, caused patient to re-breathe exhaled co2.No other negative impact.

• Brand Name: SALTER LABS
• Type of Device: SM ADULT W/MAN,MASK AND PEEP
• Manufacturer (Section D): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 13563602
• MDR Text Key: 290072610
• Report Number: 1314417-2022-00006
• Device Sequence Number: 1
• Product Code: BTM
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF5140MBP
• Device Catalogue Number: AF5140MBP
• Device Lot Number: 2110074, 2109221, 2110123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other