MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-15 for STRATAPULE PORTABLE STRATAPULSE PORTABLE NA manufactured by Shanghai Apolo Medical Tech Co Ltd..
[4922784]
On (b)(6) 2013, mr (b)(4) was repairing this device for a different problem. During his analysis be discovered that the spot size was set to 15 x 50 when it should have been 12 x 35. On (b)(6) 2014, as part of a complaint remediation investigation, i asked him about this malfunction. He stated that it was his opinion that if this malfunction recurred it could result in too much energy being delivered to the treatment area and cause permanent injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005327046-2014-00003 |
| MDR Report Key | 4115748 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-09-12 |
| Date Facility Aware | 2014-09-10 |
| Report Date | 2014-09-12 |
| Date Reported to Mfgr | 2014-09-12 |
| Date Added to Maude | 2014-09-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 12585 OLD HIGHWAY 280 STE 103 |
| Manufacturer City | CHELSEA AL 350430000 |
| Manufacturer Country | US |
| Manufacturer Postal | 350430000 |
| Manufacturer G1 | MARKET TECHNOLOGIES INC |
| Manufacturer Street | 12585 OLD HIGHWAY 280 STE 103 |
| Manufacturer City | CHELSEA AL 35043000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 35043 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATAPULE PORTABLE |
| Generic Name | IPL SYSTEM |
| Product Code | ONF |
| Date Received | 2014-09-15 |
| Model Number | STRATAPULSE PORTABLE |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | N |
| Device Age | 15 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHANGHAI APOLO MEDICAL TECH CO LTD. |
| Manufacturer Address | 3F, BLDG A, NO 388 YINDU RD XUHUI DISTRICT, SHANGHAI AL CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-15 |