MAUDE Adverse Event Report: DOREL SAFETY 1ST; HUMIDIFIER

Model Number IH414

Device Problems Thermal Decomposition of Device (1071); Crack (1135); Sparking (2595); Noise, Audible (3273)

Patient Problems Syncope (1610); Anxiety (2328); Electric Shock (2554)

Event Date 08/21/2017

Event Type  Injury  

Event Description

I recently purchased a safety1st humidifier from (b)(6).The humidifier is clearly one of their newly / recently released products.I brought the item home and used it as instructed.There seemed to be no issue, at first, just over 2 weeks after the purchase of the safety1st humidifier, around 8 pm, i plugged the device in.It was safely and securely sitting on my side table (next to my bed and my baby's bassinet).Within about 20 minutes of use (on the lowest setting), the humidifier began to spark and make loud explosive noises.There were at least 2-3 extremely loud explosions that came from the device.I attempted to turn the device off and experienced an electrical shock when my hand made contact with the device.This scared me even more, not only because it's dangerous and it hurt, but because i am (b)(6) months pregnant and i do not know if or how this will effect my unborn child.My significant other ran into the room after hearing the explosive sounds.He was in a panic because he is a veteran that suffers from ptsd, a traumatic brain injury and pre-syncope syndrome.The explosive sounds caused him to have an anxiety attack that was immediately followed a pre-syncope episode (visual blackout and loss of control over motor functions).Luckily, he was able to identify the source of the explosive noises and he immediately unplugged the safety1st humidifier.He then had an episode of fell to the floor.The next day, i went to my obgyn to have an ultrasound done and to check the heart rate of my unborn baby.Things seem to be fine, but we will not know if there has been any real damage to the development / functionality of the child until after he is born.Upon examining the unplugged device, i immediately noticed that something had burned completely through the plastic and caused two add'l very large cracks in the plastic as well.I strongly feel that if this device was plugged in a moment longer, it would have exploded completely.Because of this, i will never use another humidifier.Especially after the one named "safety1st" has proven to be the furthest thing from safe.Product description: the device is blue and white in color.Dimensions: 11.0 inches, h x 8.5 inches, w x 8.5 inches, d volts required: 120 volts, battery: no battery used, warranty: 1 year limited warranty, features: automatic shut-off.Misting option, runs quietly, removable tank, adjustable humidity control, adjustable mist settings, refill indicator capacity (volume): 0.61 galloon, misting type: cool mist, room size range: 100-300 sq., ft.Run time per fill: 24 hour, moisture output: 1.9 gallon, number of settings: variable, (b)(4), energyguide label not required: energyguide label not required.Incident location: (b)(6), united states.This is my home address.Purchased date: (b)(6) 2017.Mfr date: 05/10/2017.Document number: (b)(4).

Event Description

I recently purchased a safety1st humidifier from (b)(6).The humidifier is clearly one of their newly / recently released products.I brought the item home and used it as instructed.There seemed to be no issue, at first, just over 2 weeks after the purchase of the safety1st humidifier, around 8 pm, i plugged the device in.It was safely and securely sitting on my side table (next to my bed and my baby's bassinet).Within about 20 minutes of use (on the lowest setting), the humidifier began to spark and make loud explosive noises.There were at least 2-3 extremely loud explosions that came from the device.I attempted to turn the device off and experienced an electrical shock when my hand made contact with the device.This scared me even more, not only because it's dangerous and it hurt, but because i am (b)(6) months pregnant and i do not know if or how this will effect my unborn child.My significant other ran into the room after hearing the explosive sounds.He was in a panic because he is a veteran that suffers from ptsd, a traumatic brain injury and pre-syncope syndrome.The explosive sounds caused him to have an anxiety attack that was immediately followed a pre-syncope episode (visual blackout and loss of control over motor functions).Luckily, he was able to identify the source of the explosive noises and he immediately unplugged the safety1st humidifier.He then had an episode of fell to the floor.The next day, i went to my obgyn to have an ultrasound done and to check the heart rate of my unborn baby.Things seem to be fine, but we will not know if there has been any real damage to the development / functionality of the child until after he is born.Upon examining the unplugged device, i immediately noticed that something had burned completely through the plastic and caused two add'l very large cracks in the plastic as well.I strongly feel that if this device was plugged in a moment longer, it would have exploded completely.Because of this, i will never use another humidifier.Especially after the one named "safety1st" has proven to be the furthest thing from safe.Product description: the device is blue and white in color.Dimensions: 11.0 inches, h x 8.5 inches, w x 8.5 inches, d volts required: 120 volts, battery: no battery, used warranty: 1 year limited warranty, features: automatic shut-off.Misting option, runs quietly, removable tank, adjustable humidity control, adjustable mist settings, refill indicator capacity (volume): 0.61 galloon misting type: cool mist room size range: 100-300 sq., ft.Run time per fill: 24 hour, moisture output: 1.9 gallon, number of settings: variable, (b)(4), energyguide label not required: energyguide label not required.Incident location: (b)(6), united states.(b)(6).Purchased date: (b)(6) 2017.Mfr date: 05/10/2017.(b)(4).

• Brand Name: SAFETY 1ST
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): DOREL
• MDR Report Key: 6872039
• MDR Text Key: 86488958
• Report Number: MW5072189
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: IH414
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Age: 23 YR