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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS - AVENT 4-IN-1 ELECTRIC STEAM STERILIZER

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PHILIPS - AVENT 4-IN-1 ELECTRIC STEAM STERILIZER Back to Search Results
Model Number SCF286/05
Device Problems Melted (1385); Device Emits Odor (1425); Overheating of Device (1437); Protective Measures Problem (3015)
Patient Problems Apnea (1720); Tachycardia (2095); Complaint, Ill-Defined (2331)
Event Date 12/16/2015
Event Type  Injury  
Event Description
I purchased a philips sterilizer and used it several times a day for sterilizing my baby's bottles, nipples, and rings. The outside container of the product started melting from the overheating/hot spot on the plate underneath. So much so that we started noticing a smoky smell to the baby's bottles and nipples. It grew over time so we didn't notice it at the beginning. When we did we discontinued use immediately and contacted philips to have an fmea completed and they said they would share the results, so i knew what risk my baby had because he had been ingesting this steamed/smoked film for weeks potentially. Philips sent prepaid (b)(6) info, and after 8 months of me constantly emailing and calling back. I have had no traction on this. They didn't respond. I finally told them i was contacting the fda and they finally called not emailed back stating if there was no gas, then there was low chance of any issue. There is clearly history and i was clear in my verbal and written correspondence that there was gas on the bottles. Our doctors told us to throw everything away and get new bottles to avoid any other potential risk because we didn't know how much and for how long his feeding products were being coated with this gas. My son was born on (b)(6) 2015 and had been using this product since birth and was hospitalize at 3 weeks old for: fast heart rates, stopping breathing and a extremely low anc count of (190). He now back permanent neutropenia and has been seeing pediatric hematology for months. I am not sure if any of the failure of this product has or has not led to his health issues, but we could know more (me and his hematology doctors) if we know that materials he has had exposure to. Listed below is email correspondence history: email to (b)(6). New supervisor to be helping coordinate now. In (b)(6) 2016, after multiple requests and promises that someone would get back to me. Yes, i had been expecting a call within 48 hours from you 2 weeks ago. Thank you for now reaching out via email. This was assigned to you by (b)(6). On (b)(6) 2016, i spoke with (b)(6) and requested you, (b)(6) by name to call me because (b)(6) wasn't returning my calls. I asked that (b)(6) f/u with me in the event that you didn't call because she said you were new and in previous calls. I had asked to speak with (b)(6) supervisor to no avail. (b)(6) stated that you would call in 48 hours from (b)(6) 2016. Email to (b)(6) - today is (b)(6) 2016, and this is the first time you have reached out. On (b)(6) 2016 - i called requesting call back from you. On (b)(6) 2016, i called requesting call back from supervisor or engineer numerous other calls numerous emails. I can submit email history and dates i left messages and spoke to reps about the lack of f/u and requesting info.
 
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Brand Name4-IN-1 ELECTRIC STEAM STERILIZER
Type of DeviceSTERILIZER
Manufacturer (Section D)
PHILIPS - AVENT
MDR Report Key5769058
MDR Text Key49048054
Report NumberMW5063221
Device Sequence Number1
Product Code FLE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSCF286/05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/29/2016 Patient Sequence Number: 1
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