MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; PEDI W/MANOMETER & POP-OFF

Model Number	AF2142MB
Medical Device Problem Codes	Disconnection (1171); Connection Problem (2900)
Health Effect - Clinical Codes	Respiratory Failure (2484); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The patient expired during the use of the device, even though the clinician indicates that the device was not the cause for the patient to expire.Further communication with complaintant indicated that there was no injury/death involved with the use of this device.
Event or Problem Description
Product complaint # (b)(4) regarding our item # 87-af2142mbea- resus, ped, airfl, man, pop-off (sunmed # (b)(4)).Our customer, stephanie edwards, has reported "ambu bags / taped to back / o2 tube thru inside comes out end hook to o2 source / tube tht goes to back/exhast teethin is not connected tube is coming out.Customer states the patient did expire but did not feel because of this.They had to use 4 bags due to tube coming out." per the conversation with product quality, no injury/death was involved - stephanie edwards (complainant).
Additional Manufacturer Narrative
The patient expired during the use of the device, even though the clinician indicates that the device was not the cause for the patient to expire.Further communication with complaintant indicated that there was no injury/death involved with the use of this device.The complaint of "tube that goes to the back exhaust teeth in is not connected" regarding part number af2142mb was not able to be confirmed due to a lack of images or returned product.The root cause was not confirmed but the affected device was manufactured in 2013 and therefore was significantly past its stated shelf life of 5 years, which could have lead to degraded function.A risk assessment was performed and the ultimate risk was determined to be low which does not require initiation of a capa.There have been zero other complaints regarding the same part family and a similar issue in the 24 months preceding this reported event.A resolution email was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
Product complaint # (b)(4) regarding our item # 87-af2142mbea- resus, ped, airfl, man, pop-off (sunmed # af2142mb).Our customer, stephanie edwards, has reported "ambu bags / taped to back / o2 tube thru inside comes out end hook to o2 source / tube tht goes to back/exhast teethin is not connected tube is coming out.Customer states the paitent did expire but did not feel because of this.They had to use 4 bags due to tube coming out." per the conversation with product quality, no injury/death was involved - (b)(6) (complaintant).

• Brand Name: SUNMED LLC
• Common Device Name: PEDI W/MANOMETER & POP-OFF
• 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: 19038189
• Report Number: 1314417-2024-00017
• Device Sequence Number: 7339008
• Product Code: NHK
• UDI-Device Identifier: 10889483090237
• UDI-Public: 10889483090237
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AF2142MB
• Device Catalogue Number: AF2142MB
• Device Lot Number: 201204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Death
• Patient Sex: Unknown