COMPACT SPACE CHAMBER PLUS SP-SPAP-CE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-05-02 for COMPACT SPACE CHAMBER PLUS SP-SPAP-CE manufactured by Medical Developments International Ltd.

Event Text Entries

[107340200] Following our examination of the returned sample and investigations conducted together with our contract manufacturer (including a review of batch records and retention samples), we are unable to determine any manufacturing issue that may have caused the reported event. The silicone material used for the valves is unchanged, and there had been no changes to the design of the valve at the time of the production of this batch. Mdi has no other recorded reports of this type of event occurring in any other market. In the absence of any manufacturing issues being identified, it is most likely in our view that tearing has been caused during the cleaning of the space chamber. It is possible to damage the valve if the base is removed and the space chamber is cleaned with something like a bottle brush. Pushing though the valve with enough force may initiate tearing of the valve at the cross cut (even using a relatively blunt implement) and this tear may then be propagated through the valve, along any creases/edges in the valve. This does require a reasonable amount of force, and the use of a bottle brush or similar item is not contained in the cleaning instructions provided with the device. The space chamber should only be cleaned according to the process outlined in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10


[107340201] Patient claims that the valve tore during inhalation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005977696-2018-00002
MDR Report Key7482150
Report SourceFOREIGN
Date Received2018-05-02
Date of Report2016-05-31
Date Mfgr Received2016-05-31
Date Added to Maude2018-05-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBROOKE RYDER-SMITH
Manufacturer Street4 CARIBBEAN DRIVE
Manufacturer CitySCORESBY, VICTORIA 3179
Manufacturer CountryAS
Manufacturer Postal3179
Manufacturer G1FOREMOUNT ENTERPRISE CO., LTD.
Manufacturer StreetNO. 17, ALLEY 15, LANE 5 SHENAN STREET
Manufacturer CitySHENGANG DISTRICT, TAICHUNG CITY 42944
Manufacturer CountryTW
Manufacturer Postal Code42944
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPACT SPACE CHAMBER PLUS
Generic NameHOLDING CHAMBERS, DIRECT PATIENT INTERFACE
Product CodeNVP
Date Received2018-05-02
Model NumberSP-SPAP-CE
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDICAL DEVELOPMENTS INTERNATIONAL LTD
Manufacturer Address4 CARIBBEAN DRIVE SCORESBY, VICTORIA 3179 AS 3179


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-02

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