inforMED
MalfunctionNVP

SPACE CHAMBER PLUS

Received Jun 5, 2018

Report 3005977696-2018-00003 · MDR key 7568143

Device

Generic name

Holding Chambers, Direct Patient Interface

Model number

SP-SPAP-MAM

Lot number

04-2016

Product problems

  • Material Fragmentation
  • Material Fragmentation

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE RETURNED DEVICE WAS EXAMINED. THE CAUSE OF THE BROKEN VALVE WAS NOT DETERMINED. HOWEVER, BASED ON THE SIZE OF THE TORN VALVE AND POINT OF BREAKAGE (UNDER THE VALVE RING) FROM HE REST OF THE VALVE, THE TEAR HAPPENED OVER TIME. THE BREAKAGE COULD START SMALL AND UNDETECTED, AND OVER A PERIOD OF TIME SOMETHING MUST HAVE EXTENDED THE TEAR TO CAUSE THE VALVE TO FALL OFF. ONE OF THE POSSIBILITIES THAT COULD CAUSE THE TEAR IS USING A BOTTLE BRUSH TO CLEAN THE SPACE CHAMBER. AS OBSERVED ON THE RETURNED ITEM, THE BODY OF THE SPACE CHAMBER IS MUCH CLEARER WITH NO RESIDUE THAT THE MOUTH PIECE AND THE END CAP. USING A BRUSH DURING WASHING PROCESS COULD CAUSE A SMALL TEAR ON THE VALVE AND OVER TIME THE TEAR COULD EXTEND TO CAUSE THE VALVE TO FALL OFF. A SMALL TEAR COULD ALSO BE A DEFECT FROM THE MANUFACTURE, BUT THE DOCUMENTATION FOR THE BATCH DOES NOT SHOW ANY ATYPICAL EVENTS DURING MANUFACTURE. THEREFORE, THIS WAS FOUND NOT TO BE THE CASE. ADDITIONALLY, WE HAVE NOT HAD ANY INSTANCES OF A BROKEN VALVE IN OTHER SPACE CHAMBERS TO DATE.

Description of Event or Problem

IT WAS REPORTED THAT A SPACE CHAMBER PLUS DEVICE HAD A TORN VALVE AFTER 3-4 MONTHS OF USAGE. FURTHER DETAILS: PATIENT WASHED WITH DISHWASHING DETERGENT AND AIR DRY FOR FIRST TIME. USED TWICE DAILY. VALVE BROKE AND DROPPED INTO THE CHAMBER BODY DURING THE LAST USE.

Additional Manufacturer Narrative

THE RETURNED DEVICE WAS EXAMINED. THE CAUSE OF THE BROKEN VALVE WAS NOT DETERMINED. HOWEVER, BASED ON THE SIZE OF THE TORN VALVE AND POINT OF BREAKAGE (UNDER THE VALVE RING) FROM HE REST OF THE VALVE, THE TEAR HAPPENED OVER TIME. THE BREAKAGE COULD START SMALL AND UNDETECTED, AND OVER A PERIOD OF TIME SOMETHING MUST HAVE EXTENDED THE TEAR TO CAUSE THE VALVE TO FALL OFF. ONE OF THE POSSIBILITIES THAT COULD CAUSE THE TEAR IS USING A BOTTLE BRUSH TO CLEAN THE SPACE CHAMBER. AS OBSERVED ON THE RETURNED ITEM, THE BODY OF THE SPACE CHAMBER IS MUCH CLEARER WITH NO RESIDUE THAT THE MOUTH PIECE AND THE END CAP. USING A BRUSH DURING WASHING PROCESS COULD CAUSE A SMALL TEAR ON THE VALVE AND OVER TIME THE TEAR COULD EXTEND TO CAUSE THE VALVE TO FALL OFF. A SMALL TEAR COULD ALSO BE A DEFECT FROM THE MANUFACTURE, BUT THE DOCUMENTATION FOR THE BATCH DOES NOT SHOW ANY ATYPICAL EVENTS DURING MANUFACTURE. THEREFORE, THIS WAS FOUND NOT TO BE THE CASE. ADDITIONALLY, WE HAVE NOT HAD ANY INSTANCES OF A BROKEN VALVE IN OTHER SPACE CHAMBERS TO DATE. CORRECTION: UPDATED MODEL NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT A SPACE CHAMBER PLUS DEVICE HAD A TORN VALVE AFTER 3-4 MONTHS OF USAGE. FURTHER DETAILS: PATIENT WASHED WITH DISHWASHING DETERGENT AND AIR DRY FOR FIRST TIME USED TWICE DAILY. VALVE BROKE AND DROPPED INTO THE CHAMBER BODY DURING THE LAST USE.