MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; ADULT AIRFLOW RESUS W/MANOMETE

Model Number	AF1140MB
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The potential to put the patient at risk if not checked before stocking by the patient's bedside.
Event or Problem Description
Masks are deflated and will not properly seal on patients face.Customer stated the following: this issue is placing our patients at great risk in the event a code blue is called, the mask will not properly seal on the patients face.
Event or Problem Description
Masks are deflated and will not properly seal on patients face.Customer stated the following: this issue is placing our patients at great risk in the event a code blue is called, the mask will not properly seal on the patients face.
Additional Manufacturer Narrative
The potential to put the patient at risk if not checked before stocking by the patient's bedside.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
• Common Device Name: ADULT AIRFLOW RESUS W/MANOMETE
• 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: 17175394
• Report Number: 1314417-2023-00015
• Device Sequence Number: 3534542
• Product Code: BTM
• UDI-Device Identifier: 10889483071809
• UDI-Public: 10889483071809
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: AF1140MB
• Device Catalogue Number: AF1140MB
• Device Lot Number: 319663,2008052,2102083,392424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown