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

Model Number	AF5140MB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"this report is being submitted retrospectively per fda request".Customer complaint was confirmed.Affected devices were returned for evaluation.Twenty-three of the reported twenty-four masks were deemed to be non-conforming.A corrective action preventative action has been initiated to address this issue.We apologize for any inconvenience this may have caused and appreciate you contacting us regarding this incident as we continually monitor and analyze complaints data as part of our continuous improvement efforts.Only the masks were sent, no resuscitator bags.Samples were not labelled which lot they were from, but the removed polybags were included.Only 23 masks included, with varying levels of mask port deformation, from minor to severe.The original affected lot from the customer was 313909.Replacement material was sent from distributor in arlington tx to the customer and the additional 5 lot numbers of effected devices were found in the replacement material.All masks are 100% inspected before packaging with the resuscitation bag.Rates of raw mask material port roundness are noted below.313909: 0/1500 mask port out of roundness, no product replaced 315059: 40/1500 mask port out of roundness, all product rejected replaced with conforming material 312282: 33/1500 mask port out of roundness, all product rejected replaced with conforming material 314649: 31/1500 mask port out of roundness, all product rejected replaced with conforming material 314795: 60/1500 mask port out of roundness, all product rejected replaced with conforming material 313061: 25/1500 mask port out of roundness, all product rejected replaced with conforming material product returned from customer was tested on a sample patient port and 5/23 mask ports were unable to fit onto the patient port.The rest of the parts were able to fit onto the patient port with light to moderate force.
Event or Problem Description
Customer states that masks on resus bags are warped.
Additional Manufacturer Narrative
"this report is being submitted retrospectively per fda request".Customer complaint was confirmed.Affected devices were returned for evaluation.Twenty-three of the reported twenty-four masks were deemed to be non-conforming.A corrective action preventative action has been initiated to address this issue.We apologize for any inconvenience this may have caused and appreciate you contacting us regarding this incident as we continually monitor and analyze complaints data as part of our continuous improvement efforts.Only the masks were sent, no resuscitator bags.Samples were not labelled which lot they were from, but the removed polybags were included.Only 23 masks included, with varying levels of mask port deformation, from minor to severe.The original affected lot from the customer was 313909.Replacement material was sent from distributor in arlington tx to the customer and the additional 5 lot numbers of effected devices were found in the replacement material.All masks are 100% inspected before packaging with the resuscitation bag.Rates of raw mask material port roundness are noted below.313909: 0/1500 mask port out of roundness, no product replaced.315059: 40/1500 mask port out of roundness, all product rejected replaced with conforming material 312282: 33/1500 mask port out of roundness, all product rejected replaced with conforming material 314649: 31/1500 mask port out of roundness, all product rejected replaced with conforming material 314795: 60/1500 mask port out of roundness, all product rejected replaced with conforming material 313061: 25/1500 mask port out of roundness, all product rejected replaced with conforming material.Product returned from customer was tested on a sample patient port and 5/23 mask ports were unable to fit onto the patient port.The rest of the parts were able to fit onto the patient port with light to moderate force.
Event or Problem Description
Customer states that masks on resus bags are warped.

• Brand Name: SUNMED 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: 7980434
• Report Number: 1314417-2018-00043
• Device Sequence Number: 14896008
• Product Code: BTM
• UDI-Device Identifier: 10889483103012
• UDI-Public: 10889483103012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2018

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
• Operator of Device: Health Professional
• Device Model Number: AF5140MB
• Device Catalogue Number: AF5140MB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018; 09/24/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/18/2018; 06/20/2023
• 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