MAUDE Adverse Event Report: ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD. IOS ICE MAX; POWERED LASER SURGICAL INSTRUMENT

Device Problems Product Quality Problem (1506); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

I have purchased 3 wavelength diode laser hair removal machine which is called ios ice max from pz laser in (b)(6).They have supplied fda and ce certificates during our sales negotiation, therefore i have relied on these certificates to make my decision to purchase this machine.I have purchased the machine in (b)(6) 2020 and received the delivery in (b)(6) 2021 during when we were on national covid 19 lock down (b)(6).I have tested the machine beginning of (b)(6) 2021 just before reopening on (b)(6) 2021 and realized that the head piece cooling is very poor, after about 500 shoots the head piece temperature on the sapphire head is reaching the 36 degrees, on the other hand i have been marketed the machine with the technical specifications showing head temperature as -5 degrees.I have contacted with pz laser about this issue initially they have tried to deny the problem but eventually they have accepted the fault as it's the factory design fault not a part fault due to all the other buyer are suffering for the same problem.Pz laser said that they are working on it to upgrade the handle that i am waiting for almost a year for the resolve but this model is out in the market for more than 2 years, still pz laser could not upgrade the handle and they are not neither offering refund or exchange.This model machine is not safe to carry out successful treatment with this poor cooling level.Fda safety report id# (b)(4).

• Brand Name: IOS ICE MAX
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD.
• MDR Report Key: 12953658
• MDR Text Key: 281937693
• Report Number: MW5105862
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other