MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING; METER, AIRWAY PRESSURE (INSPIRATORY FORCE)

Model Number	55-6060
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the red indicator needle does not move with the black needle when under pressure.No patient injury was reported.
Additional Manufacturer Narrative
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.One unit was received, not in its original package, therefore the labeling of the box could not be evaluated.The unit received is the correct part number specified in the complaint.The units are 100% functional tested and visually inspected prior to packaging and shipment.The unit was tested per internal test procedures and met all the specifications.The gauge is accurate both ways, pressure and vacuum.The red indicator needle for this part number is not intended to move with the black needle when under pressure.There was no fault found on this device.No corrective actions are planned at this time.The manufacture regularly analyzes complaint data and trends and will take further actions accordingly.Operator of device is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING
• Common Device Name: 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; 1702 20th st w; minneapolis, MN 55442
• MDR Report Key: 15444999
• Report Number: 3012307300-2022-19572
• Device Sequence Number: 15335987
• Product Code: BXR
• UDI-Device Identifier: 10788942560604
• UDI-Public: 10788942560604
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K873498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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 Expiration Date: 07/04/2021
• Device Model Number: 55-6060
• Device Catalogue Number: 55-6060
• Device Lot Number: 3217021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown