MAUDE Adverse Event Report: SUNMED HOLDINGS LLC VENTLAB LLC; .5 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER

Model Number	HS4051
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient in the pacu required support with breathing.The peeps' inability to dial into the appropriate setting would cause the neonates oxygen saturation to drop.This delayed therapy and caused the neonate to be put on a ventilator.
Event or Problem Description
The peep on the manometer wasn't working correctly.The patient was put on a vent.
Additional Manufacturer Narrative
The patient in the pacu required support with breathing.The peeps' inability to dial into the appropriate setting would cause the neonates oxygen saturation to drop.This delayed therapy and caused the neonate to be put on a ventilator.The complaint of " the peep on the manometer wasn't working correctly." regarding part (b)(6) was not confirmed.The root cause was not determined since the issue described by the customer could not be replicated during functional testing.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
The peep on the manometer wasn't working correctly.The patient was put on a vent.

• Brand Name: VENTLAB LLC
• Common Device Name: .5 LITRE HYPERINFLATION BAG SYSTEM 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: 18743617
• Report Number: 1314417-2024-00013
• Device Sequence Number: 6396202
• Product Code: NHK
• UDI-Device Identifier: 10889483105214
• UDI-Public: 10889483105214
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/20/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: HS4051
• Device Catalogue Number: HS4051
• Device Lot Number: 230600467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/24/2024
• 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
• Patient Sex: Unknown