PNEUPAC VENTILATOR
Received Feb 23, 2022 · Event occurred Jan 19, 2022
Report 3012307300-2022-04007 · MDR key 13587955
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Product problems
- Failure to Deliver Energy
- No Device Output
- Failure to Deliver Energy
- No Device Output
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 WAS NOT FUNCTIONING OR VENTILATING PROPERLY. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE SMITHS TAMPERED SEALS INTACT, DEVICE IS MISSING THE PATIENT VALVE COVER. THE CUSTOMER STATED PROBLEM WAS DUPLICATED, WHEN DEVICE WAS TURNED ON TO AUTO, DEVICE DID NOT VENTILATE. REPLACED FAULTY MOMENTARY VALVE, REPLACED UPPER AND LOWER HOUSING, REPLACED PATIENT VALVE, INSTALLED NEW SINTERED FILTER. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. THE PREVIOUS SERVICE HISTORY HAS BEEN REVIEWED AND IS UNRELATED TO THE CURRENT CUSTOMER REPORTED PROBLEM. THE MANUFACTURING DHR IS NOT RELEVANT TO THE INVESTIGATION DUE TO THE AGE OF THE DEVICE.
Additional Manufacturer Narrative
B5: ADDITIONAL INFO RECEIVED VIA EMAIL (B)(6)2022. EVENT DATE UPDATED (B)(6) 2022). NO PATIENT INVOLVEMENT WAS REPORTED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE SMITHS TAMPERED SEALS INTACT, DEVICE IS MISSING THE PATIENT VALVE COVER. THE CUSTOMER STATED PROBLEM WAS DUPLICATED, WHEN DEVICE WAS TURNED ON TO AUTO, DEVICE DID NOT VENTILATE. REPLACED FAULTY MOMENTARY VALVE, REPLACED UPPER AND LOWER HOUSING, REPLACED PATIENT VALVE, INSTALLED NEW SINTERED FILTER. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. THE PREVIOUS SERVICE HISTORY HAS BEEN REVIEWED AND IS UNRELATED TO THE CURRENT CUSTOMER REPORTED PROBLEM. THE MANUFACTURING DHR IS NOT RELEVANT TO THE INVESTIGATION DUE TO THE AGE OF THE DEVICE.