MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; METER, AIRWAY PRESSURE (INSPIRATORY FORCE)

Model Number 55-6060

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2020

Event Type  malfunction  

Event Description

It was reported that the functional teste failed.After testing with positive and negative pressure using a small syringe, the gauge pointer cannot return to zero and stops at just outside the edge of the black square.No patient injury was reported.

Manufacturer Narrative

Operator of device is unknown.No information has been provided to date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.No problem was found.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was tested and successfully passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: PORTEX
• Type of Device: METER, AIRWAY PRESSURE (INSPIRATORY FORCE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 1 lung tak st.; minneapolis, MN 55442
• MDR Report Key: 15445578
• MDR Text Key: 306238971
• Report Number: 3012307300-2022-19607
• Device Sequence Number: 1
• Product Code: BXR
• UDI-Device Identifier: 10788942560604
• UDI-Public: 10788942560604
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K873498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 55-6060
• Device Catalogue Number: 55-6060
• Device Lot Number: 3898024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1