MAUDE Adverse Event Report: WELCH ALLYN INC SMARTCARE CONNECT PREMIUM PLUS - TIER D; SPIROMETER, DIAGNOSTIC

Model Number	CPWS
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that incorrect reports were auto attaching to the wrong patient file.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #: (b)(4).
Additional Manufacturer Narrative
Additional information has been requested regarding the reported incident, a final report will be submitted upon completion of the investigation.

• Brand Name: SMARTCARE CONNECT PREMIUM PLUS - TIER D
• Common Device Name: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: mauricio cerecer ; 1069 state route 46 east; batesville, IN 47006
• MDR Report Key: 24757348
• Report Number: 1316463-2026-00018
• Device Sequence Number: 9138254
• Product Code: BZG
• UDI-Device Identifier: 00732094301212
• UDI-Public: (01)00732094301212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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 Model Number: CPWS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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