MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX ACAPELLA VIBRATORY PEP RESPIRATORY THERAPY SYSTEM; SPIROMETER, THERAPEUTIC (INCENTIVE)

Catalog Number	27-9000
Medical Device Problem Code	Ventilation Problem in Device Environment (3027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.: unknown; no information has been provided to date.E.1.: initial reporter phone: (b)(6).H.3.: 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 reportable information becomes available.
Event or Problem Description
It was reported that the device became dry and was unable to inhale or draw an air through.The event occurred after using.There was a patient involvement, but no patient injury reported.
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX ACAPELLA VIBRATORY PEP RESPIRATORY THERAPY SYSTEM
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): ICU MEDICAL, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23584622
• Report Number: 3012307300-2025-12563
• Device Sequence Number: 18456512
• Product Code: BWF
• UDI-Device Identifier: 10788942290006
• UDI-Public: (01)10788942290006(17)270601(10)4391343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 27-9000
• Device Lot Number: 4391343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown