MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED HOLDINGS LLC; SMALL ADULT AIRFLOW W/MANOMETER

Model Number	AF5140MB
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable as not able to provide respiratory support to the patient.The bvm malfunctioning would potentially lower the volume delivered to the patient.Based on the reported information, the criteria for reporting an adverse event have been met.
Event or Problem Description
Bvm malfunctioned and patient was not able to be ventilated for an unknown reason.
Additional Manufacturer Narrative
Reportable as not able to provide respiratory support to the patient.The bvm malfunctioning would potentially lower the volume delivered to the patient.Based on the reported information, the criteria for reporting an adverse event have been met.Summary: returned product confirmed the complaint.During investigation of the device without a manufacturing date/lot number, it was found that the device was made prior to certain engineering changes dating to 2015.Ra: rma-20020 contains appropriate risk assessment.Previous corrective actions of capa14-016 and mi-co19-0225 address the non-conformance identified by this complaint.
Event or Problem Description
Bvm malfunctioned and patient was not able to be ventilated for an unknown reason.

• Brand Name: SUNMED HOLDINGS LLC
• Common Device Name: SMALL ADULT AIRFLOW W/MANOMETER
• 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: 15827984
• Report Number: 1314417-2022-00021
• Device Sequence Number: 12301341
• Product Code: BTM
• UDI-Device Identifier: 10889483103012
• UDI-Public: 10889483103012
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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
• Operator of Device: Other
• Device Model Number: AF5140MB
• Device Catalogue Number: AF5140MB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 25 YR
• Patient Sex: Male