MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX MANUAL RESUSCITATION 1ST RESPONSE AD; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number	8503F
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is missing the expiration date.No patient injury was reported.
Additional Manufacturer Narrative
Review of changes relevant to the product and lot numbers reported determined that the absence of the product expiration date was not the result of a manufacturing related issue, but part of a change to our product's packaging, per customer feedback.A manufacturing device history record (dhr) review request was sent to the supplier; no further information has been made available to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX MANUAL RESUSCITATION 1ST RESPONSE AD
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15433719
• Report Number: 3012307300-2022-19343
• Device Sequence Number: 5673703
• Product Code: BTM
• UDI-Device Identifier: 15019315060908
• UDI-Public: 15019315060908
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K014115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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 Model Number: 8503F
• Device Catalogue Number: 8503F
• Device Lot Number: 191105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/15/2022
• 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