MalfunctionBTM
SUNMED
Received Mar 1, 2024 · Event occurred Jun 27, 2023
Report 1314417-2024-00015 · MDR key 18822925
Device
Generic name
Unknown
Manufacturer
Sunmed Holdings LlcModel number
UNKNWONCatalog number
UKNOWN
Lot number
UNKNOWN
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MANUAL RESUSCITATOR HAVING HIGH CO2 LEVELS COULD BE HARMFUL TO PATIENT THERAPY. WITHOUT A PART#, RETURNED PRODUCT, OR ANY FURTHER INFORMATION, COMPLAINT CANNOT BE INVESTIGATED AND WILL BE CLOSED. FOLLOW UP REQUESTS HAVE NOT RESULTED IN ANY MORE INFORMATION.
Description of Event or Problem
CONCERN WITH HIGH CO2 LEVELS.
Additional Manufacturer Narrative
THE MANUAL RESUSCITATOR HAVING HIGH CO2 LEVELS COULD BE HARMFUL TO PATIENT THERAPY.
Description of Event or Problem
CONCERN WITH HIGH CO2 LEVELS.