MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; ADULT AIRFLOW W/PEEP VALVE

Model Number	AF1140MB-P
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	12/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken bag would delay the intubations of the patient.Based on the reported information and the adverse event originating in the united states, the criteria for reporting an adverse event have not been met.
Event or Problem Description
During intubation the bag broke apart.Possible delay in intubation but no details given on the patient affect.
Additional Manufacturer Narrative
The broken bag would delay the intubations of the patient.Based on the reported information and the adverse event originating in the united states, the criteria for reporting an adverse event have not been met.Summary: attempts to get information from the end-user was unsuccessful to determine the location of the device break.It is likely that the patient valve was not fully connected to the resuscitation bag body.Ra: rma-20020 r37 "device cannot perform as intended" identifies potential broken resuscitation bags not able to perform as intended.No update to rma required.
Event or Problem Description
During intubation the bag broke apart.Possible delay in intubation but no details given on the patient affect.

• Brand Name: SUNMED LLC
• Common Device Name: ADULT AIRFLOW W/PEEP VALVE
• 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: 16386883
• Report Number: 1314417-2023-00005
• Device Sequence Number: 5514746
• Product Code: BTM
• UDI-Device Identifier: 10889483098370
• UDI-Public: 10889483098370
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/16/2023

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-P
• Device Catalogue Number: AF1140MB-P
• Device Lot Number: 385843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/30/2023
• 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 Sex: Unknown