PORTEX MANUAL RESUSCITATION 1ST RESPONSE AD
Received Sep 15, 2022 · Event occurred Mar 27, 2020
Report 3012307300-2022-19343 · MDR key 15433719
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Smiths Medical International, Ltd.Model number
8503FCatalog number
8503F
Lot number
191105
Product problems
- Missing Information
- Missing Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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).