MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP HUDSON RCI; SPIROMETER,INCNTIV,VOLDYNE,4000ML

Catalog Number	HUD8884719010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the customer called as he was given the spirometers at the hospital after surgery, but now the product won't work correctly.The cylinder won't move upright, unless he uses it upside down.3 days later customer confirmed it is working now correctly and that maybe the ring in the cylinder was stuck.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that the customer called as he was given the spirometers at the hospital after surgery, but now the product won't work correctly.The cylinder won't move upright, unless he uses it upside down.3 days later customer confirmed it is working now correctly and that maybe the ring in the cylinder was stuck.

• Brand Name: HUDSON RCI
• Common Device Name: SPIROMETER,INCNTIV,VOLDYNE,4000ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes drive; northfield IL 60093 2753
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25324764
• Report Number: 1417592-2026-01807
• Device Sequence Number: 10128556
• Product Code: BWF
• UDI-Device Identifier: 10197344010356
• UDI-Public: 10197344010356
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K182847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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
• Device Catalogue Number: HUD8884719010
• Device Lot Number: 26COA570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown