INFANT SINGLE-USE RESUSCITATOR + PRESSURE RELIEF + MASK
Received Jan 26, 2023 · Event occurred Aug 16, 2021
Report 3006061749-2022-00029 · MDR key 16245801
Device
Generic name
Infant Single-use Resuscitator
Manufacturer
Flexicare Medical LtdCatalog number
038-73-940
Lot number
190102853
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS EVENT IS BEING REPORTED UNDER MDSAP REQUIREMENTS WHERE IF AN EVENT TAKES PLACE IN A MDSAP COUNTRY, AND THAT DEVICE IS SOLD IN THE USA THE EVENT SHOULD ALSO BE REPORTED TO THE FDA.
Description of Event or Problem
EVENT DESCRIPTION AS GIVEN TO MANUFACTURER "THE NURSE OPENED THE PACK TO FIND NO MASK INCLUDED. THE PACK WAS SEALED AND OBVIOUSLY SENT TO US IN THIS STATE. GIVEN THE CRITICAL NATURE OF THE PRODUCT THRUST YOU CAN SEE THE SERIOUSNESS OF THIS QUALITY FAILURE". NO PATIENT HARMED REPORTED, ANOTHER ONE WAS USED FROM A DIFFERENT CRASH CART.