MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX COACH 2 4001 SPIROMETER; 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	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that air leaked during use.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: received 1 decontaminated sample of (b)(6) lot 4412602.Visual inspection found nothing broken, cracked or missing.Functional testing of sample (b)(6) lot 4412602 performed by quality inspector for airway products.M-444 oxygen path pressure drop test - coach; passes at 2.1 inches of water, max allowable is 20; all equipment within calibration.M-445 inhalation resistance test - coach; passes at 1.4 inches of water; max allowable is 1.8; all equipment within calibration.The unit was tested per test procedures and the unit passed functional tests.The units are 100% functional tested and visually inspected prior to packaging and shipping.The unit meets specifications, and the defect could not be confirmed.The units are 100% functional tested and visually inspected prior to packaging and shipping.No additional corrective actions are planned at this time.Icu medical regularly analyzes complaint data and trends and will take further actions accordingly.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX COACH 2 4001 SPIROMETER
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20029328
• Report Number: 1526863-2024-00080
• Device Sequence Number: 8674583
• Product Code: BWF
• UDI-Device Identifier: 10788942240001
• UDI-Public: (01)10788942240001(17)280709(10)4412602
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: 22-4000
• Device Lot Number: 4412602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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