MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-06-05 for SPACE CHAMBER PLUS SP-SPAP-MAM manufactured by Medical Developments International Ltd.
[110035702]
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.
Patient Sequence No: 1, Text Type: N, H10
[110035703]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005977696-2018-00003 |
| MDR Report Key | 7568143 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-06-05 |
| Date of Report | 2018-05-17 |
| Date Mfgr Received | 2018-05-17 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2018-06-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BROOKE RYDER-SMITH |
| Manufacturer Street | 4 CARIBBEAN DRIVE |
| Manufacturer City | SCORESBY, VICTORIA 3179 |
| Manufacturer Country | AS |
| Manufacturer Postal | 3179 |
| Manufacturer G1 | FOREMOUNT ENTERPRISE CO., LTD. |
| Manufacturer Street | NO. 17, ALLEY 15, LANE 5 SHENAN STREET |
| Manufacturer City | SHENGANG DISTRICT, TAICHUNG CITY 42944 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 42944 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACE CHAMBER PLUS |
| Generic Name | HOLDING CHAMBERS, DIRECT PATIENT INTERFACE |
| Product Code | NVP |
| Date Received | 2018-06-05 |
| Returned To Mfg | 2018-05-24 |
| Model Number | SP-SPAP-MAM |
| Lot Number | 04-2016 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEVELOPMENTS INTERNATIONAL LTD |
| Manufacturer Address | 4 CARIBBEAN DRIVE SCORESBY, VICTORIA 3179 AS 3179 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-05 |