MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. VOLUME INCENTIVE SPIROMETERS; SPIROMETER, THERAPEUTIC (INCENTIVE)

Catalog Number	22-4000
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: day is unknown, month and year are known.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that, "unable to use due to air leakage." the event occurred during infusion at patient's home.There was a patient involvement, but no harm/adverse event reported.There was no disinfection or sterilization, and no infectious disease occurred.
Additional Manufacturer Narrative
After further review, this was found to be a non-reportable event.The event does not meet the definition of a reportable death or serious injury as the malfunction of the device did not cause or contribute to a patient death, a life-threatening event, permanent impairment of a body function or structure, required medical or surgical intervention to preclude serious impairment of a body structure or function.Additionally, the reportable malfunctions list indicates that the device in the reported incident would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, mfr# 3012307300-2025-00526-00 will be cancelled.

• Brand Name: VOLUME INCENTIVE SPIROMETERS
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21118460
• Report Number: 3012307300-2025-00526
• Device Sequence Number: 7610854
• Product Code: BWF
• UDI-Device Identifier: 10788942240001
• UDI-Public: (01)10788942240001(17)290418(10)6002729
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: Lay User/Patient
• Device Catalogue Number: 22-4000
• Device Lot Number: 6002729
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/28/2025
• 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
• Patient Sex: Unknown