MAUDE Adverse Event Report: SHANGHAI APOLO MEDICAL TECH CO LTD. STRATAPULE PORTABLE; IPL SYSTEM

Model Number STRATAPULSE PORTABLE

Device Problem Accessory Incompatible (1004)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

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.

• Brand Name: STRATAPULE PORTABLE
• Type of Device: IPL SYSTEM
• Manufacturer (Section D): SHANGHAI APOLO MEDICAL TECH CO LTD.; 3f, bldg a, no 388 yindu rd; xuhui district, shanghai AL ; CH
• Manufacturer (Section G): MARKET TECHNOLOGIES INC; 12585 old highway 280 ste 103; chelsea AL 35043 000
• Manufacturer Contact: 12585 old highway 280 ste 103; chelsea, AL 35043-0000
• MDR Report Key: 4115748
• MDR Text Key: 4922784
• Report Number: 3005327046-2014-00003
• Device Sequence Number: 1
• Product Code: ONF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: STRATAPULSE PORTABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/10/2014
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 09/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1