MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX COACH 2 INCENTIVE SPIROMETERS; SPIROMETER, THERAPEUTIC (INCENTIVE)

Model Number	22-2500
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the bottom part of the product was chipped (and/or missing).No patient involvement.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.Please disregard the initial report submitted with the mfr number: 3012307300-2022-06231.The report was submitted in error, corrected data: corrected information provided in h10.

• Brand Name: PORTEX COACH 2 INCENTIVE SPIROMETERS
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14085881
• Report Number: 3012307300-2022-06231
• Device Sequence Number: 5276593
• Product Code: BWF
• UDI-Device Identifier: 10788942225008
• UDI-Public: 10788942225008
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 22-2500
• Device Catalogue Number: 22-2500
• Device Lot Number: 4160293
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/23/2022
• 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: 03/18/2022
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown