MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED HOLDINGS LLC; 1 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER

Model Number	HS4011
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A near miss occurred where positive pressure was desired and the valve was turned clockwise with the expectation of increasing pressure, however this led to decreasing pressure in the hyperinflation system.If not corrected immediately patient would be impacted and serious harm could occur.Based on the reported information the criteria for reporting an adverse event have been met.
Event or Problem Description
The committee on technology for the anesthesia patient safety foundation received a report regarding our hyperinflation system describing the design as counter-intuitive and that it does not conform with iso standard recommendations.A near miss occurred where positive pressure was desired and the valve was turned clockwise with the expectation of increasing pressure, however this led to decreasing pressure in the hyperinflation system.The problem was remedied by quick observation that to close the valve, the valve must be turned anti-clockwise.

• Brand Name: SUNMED HOLDINGS LLC
• Common Device Name: 1 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: 14569757
• Report Number: 2028807-2022-00014
• Device Sequence Number: 5779547
• Product Code: BTM
• UDI-Device Identifier: 10889483110850
• UDI-Public: 10889483110850
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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 Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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: HS4011
• Device Catalogue Number: HS4011
• Device Lot Number: 210700765
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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