MAUDE Adverse Event Report: SUNMED HOLDINGS LLC VENTLAB; HYPER ELBOW W/MANOMETER

Model Number	HS4000
Medical Device Problem Codes	Component Missing (2306); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	02/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Blue cap covering port was missing. attempted to use ventilating bag device, initially ventilating well, then noted to not have chest rise and difficulty ventilating or achieving adequate saturations.This improved upon switching the bag but patient experienced bradycardia requiring intervention.Upon closer look at the device respiratory therapist noted that blue cap covering a port was missing.
Additional Manufacturer Narrative
The blue cap covering the port missing prevented the patient from receiving proper ventilation.The result required the clinician to switch bags and caused the patient to experience bradycardia which required intervention.
Event or Problem Description
Blue cap covering port was missing. attempted to use ventilating bag device, initially ventilating well, then noted to not have chest rise and difficulty ventilating or achieving adequate saturations.This improved upon switching the bag but patient experienced bradycardia requiring intervention.Upon closer look at the device respiratory therapist noted that blue cap covering a port was missing.
Additional Manufacturer Narrative
The blue cap covering the port missing prevented the patient from receiving proper ventilation.The result required the clinician to switch bags and caused the patient to experience bradycardia which required intervention blue cap could have been missed during assembly operations or fallen off into the zip bag packaging the device is shipped in.The missing cap could escape the risk-based sampling plan of incoming inspection for this device.A 2 year complaint history search for hs4000 product identifies zero (0) additional complaints found for missing components.Ra: rma-20020 rev 2 indicates the severity associated with risk id r37 "mfg error - component is missing from the packaging" with severity of 7 - extreme.

• Brand Name: VENTLAB
• Common Device Name: HYPER ELBOW 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: 16776824
• Report Number: 1314417-2023-00009
• Device Sequence Number: 15121004
• Product Code: NHK
• UDI-Device Identifier: 10889483084823
• UDI-Public: 10889483084823
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/20/2023

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: HS4000
• Device Catalogue Number: HS4000
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/24/2023
• 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: Required Intervention
• Patient Age: 5 MO
• Patient Sex: Female
• Patient Weight: 4 KG
• Patient Race: Black Or African American