MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; SM ADULT AIRFLOW RESUS BAG

Model Number AF5040MB

Device Problem Material Integrity Problem (2978)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/17/2023

Event Type  malfunction  

Event Description

Face masks inside the kit are flat (underinflated).

Manufacturer Narrative

The mask deflating and not properly sealing to patient would cause a disruption in resuscitation efforts and put them at risk.

Event Description

Face masks inside the kit are flat(underinflated).

Manufacturer Narrative

The mask deflating and not properly sealing to patient would cause a disruption in resuscitation efforts and put them at risk.Summary: complaint confirmed via returned devices.The masks are able to be inflated and used properly.The customer was notified of potential causes for deflated masks.Ra: instructions for mask use in combination with rma-20020 are sufficient risk analysis for the reported product complaint.

• Brand Name: SUNMED LLC
• Type of Device: SM ADULT AIRFLOW RESUS BAG
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 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: 17279423
• MDR Text Key: 318959376
• Report Number: 1314417-2023-00018
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10889483079126
• UDI-Public: 10889483079126
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF5040MB
• Device Catalogue Number: AF5040MB
• Device Lot Number: 21300279
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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