inforMED
MalfunctionBTM

THE BAG II RESUSCITATOR

Received Feb 8, 2018

Report 9610483-2018-00002 · MDR key 7251973

Device

Generic name

Manual Emergency Ventilator

Model number

THE BAG II

Catalog number

845211

Lot number

UNK

Product problems

  • Ambient Temperature Problem
  • Device Operational Issue
  • Activation Failure
  • Ambient Temperature Problem
  • Device Operational Issue
  • Activation Failure

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Patient Involvement
  • No Consequences Or Impact To Patient
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

THE USER'S TEMPERATURE TESTED RESUSCITATOR HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

THE PREHOSPITAL SERVICE DEPARTMENT OF A NON-US HOSPITAL REPORTED THE BAG II RESUSCITATOR'S ABILITY TO RE-INFLATE STARTS TO SLOW AT -7 DEGREES CELSIUS AND BY -18 C (DFU, MINIMUM OPERATING TEMP) THE VENTILATION BAG DOES NOT RE-INFLATE AT ALL; AS FOUND DURING THEIR IN-HOUSE TEMPERATURE TESTING. THEY REPORTED THEY HAVE PREVIOUSLY SUBMITTED SEVERAL NONCONFORMANCE REPORTS TO THEIR LOCAL HEALTH AUTHORITIES FOR OTHER PATIENT INCIDENTS (NO DETAILS PROVIDED) BUT DURING THESE TEMPERATURE TESTS NO PATIENT WAS INVOLVED NOR HARMED.