MAUDE Adverse Event Report: MAXTEC, LLC EYEMAX2 PHOTOTHERAPY MASK

Model Number R300P02 PREEMIE EYEMAX2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Airway Obstruction (1699); Apnea (1720)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Maxtec investigation: the eyemax2 phototherapy eye mask is intended for neonatal eye protection during phototherapy treatment of jaundice.The mask is a single patient use, one-piece wrap-around design, which has two attachment points that may be adjusted independently to prevent unwanted movement of the mask.The eyemax2 eye masks come in three sizes, micro (occipital frontal circumference (ofc) 20-25 cm), preemie (ofc 26-32 cm) and regular (ofc 33-38cm).Each size eyemax2 is designed to fit snug on the baby's head when the correct size of the eyemax2 is selected for the circumference measurements of the baby's head.The reported incident identified that the mask had slipped down covering the infant's nose and mouth on three occasions.(note: based on the details of the facility's report, the respiratory arrest was not correlated to the obstruction event.) the instructions for use (ifu) includes a statement that identifies the size of the mask to be used relative to the occipital frontal circumference (ofc) of the baby's head.Further, the ifu includes a statement that the eyemax2 mask should be replaced if the eye mask becomes over-stretched.Maxtec was unable to obtain the eyemax2 mask or the associated manufacturing lot number to evaluate the product.An investigation was conducted based on the information available and probable causes based on our internal risk files.The investigation concluded that the probable cause of the incident was use error.See the following summary of the results of our evaluation.Manufacturing defect - the nurse communicated that there were three incidents over two years.A review of our complaint files for the eyemax2 (date range: (b)(6) 2020) revealed 0 (zero) additional complaints received for mask slippage over the same timeframe.In addition, due to the time lapse between occurrences it is unlikely that the masks utilized were from the same manufacturing lot.No information indicating a product defect was received.Based on the information available the probable root cause does not appear to be related to a manufacturing defect or product malfunction.The mask(s) in question were not returned for evaluation nor were the lot numbers provided to assist in confirmation of the root cause.Over-stretched: the mask(s) were not returned for evaluation, however, no information was received indicating that the masks visually appeared to be over-stretched.In addition, the ifu states to replace the eyemax2 with a new one if it becomes over-stretched.The mask(s) in question were not returned for evaluation to assist in confirmation of the root cause however, the use of an over-stretched mask would be indicative of a use error based on the ifu.Use error based on the ifu the patient's occipital frontal circumference (ofc) must be measured to determine the correct size of the eyemax2 mask to be used.As the reporting facility did not have a practice in place to document the ofc, we were unable to confirm that the correct size was used.Based on the following the probable cause has been identified as use error: the selection of a mask "too large" may result in slippage.The incidents in question occurred at a single facility.No other related complaints, or adverse reports have been received for the eyemax2 mask in the timeframe identified.Although, the probable root cause was use error based on the investigation , maxtec has conducted a formal review of the eyemax2 risk file considering the adverse event in accordance with iso 14971:2019.A revision of the applicable instructions for use was initiated for improved clarity historical data review: the following are results from the maude database, product code: (b)(4), date range 2010- 2020 4 events related to slippage or nose / mouth obstruction were reported for phototherapy eye masks.None of the 4 events reported involved eyemax2 masks / maxtec products.No additional adverse event reports were found for the eyemax2 phototherapy masks since the product launch in 2007.The 3 occurrences reported in the eu mhra mir 2019/010/022/401/011 incident report triggering this filing, occurred in one individual facility and department.A review of our complaint files for the eyemax2 (date range: (b)(6) 2017 to (b)(6) 2020) revealed 0 (zero) additional complaints received for mask slippage over the same timeframe.Additional note: maxtec was originally made aware of an incident reported to the mhra in the uk on january 31, 2020.Although the product was unavailable for return an investigation was performed, maxtec appropriately filed a manufacturer incident report, and resolved the matter with mhra.On october 22, 2020, a review of adverse events conducted by the new vp of quality and regulatory affairs uncovered that the adverse event issued by the foreign establishment had not been filed with the us fda.An mdr evaluation was conducted in accordance with us fda 21cfr part 803.It was determined that a 30-day report to the fda was warranted.The date of awareness for this purpose was october 22, 2020.

Event Description

Adverse event reported via eu mhra mir 2019/010/022/401/011: narrative from mhra adverse incident report as filed by nurse: "we had three incidents in the last 2 years when the eye goggles have slipped down, and obstructed the infant's nose and mouth.The first two incidents appeared to have resulted in an increase in the work of breathing (including sternal recession).This third incident that happened last week on infant was born at (b)(6) weeks and (b)(6) days old on admission and the eyemax2 preemie caused the apnea alarm to go off.The infant had shallow breathing appeared to recover but 40 minutes later had a respiratory arrest.We can't be sure the two events are linked but it is a worrying coincidence.Since the previous incident we have added an hourly checklist that the mask is in the correction position and on each bassinet there are instructions on the fitting and application of the mask." maxtec investigation: the eyemax2 phototherapy eye mask is intended for neonatal eye protection during phototherapy treatment of jaundice.The mask is a single patient use, one-piece wrap-around design which has two attachment points that may be adjusted independently to prevent unwanted movement of the mask.The eyemax2 eye masks come in three sizes, micro (occipital frontal circumference (ofc) 20-25 cm), preemie (ofc 26-32 cm) and regular (ofc 33-38cm).Each size eyemax2 is designed to fit snug on the baby's head when the correct size of the eyemax2 is selected for the circumference measurements of the baby's head.The reported incident identified that the mask had slipped down covering the infant's nose and mouth on three occasions.(note: based on the details of the facility's report, the respiratory arrest was not correlated to the obstruction event.) the instructions for use (ifu) includes a statement that identifies the size of the mask to be used relative to the occipital frontal circumference (ofc) of the baby's head.Further, the ifu includes a statement that the eyemax2 mask should be replaced if the eye mask becomes over-stretched.Maxtec was unable to obtain the eyemax2 mask to evaluate the product therefore an investigation was conducted based on the information available, and probable causes based on our internal risk file.The investigation concluded that the probable cause of the incident was use error.See the following summary of the results of our evaluation.Manufacturing defect: he nurse communicated that there were three incidents over two years.A review of our complaint files for the eyemax2 (date range (b)(6) 2020) revealed 0 (zero) additional complaints received for mask slippage over the same timeframe.In addition, due to the time lapse between occurrences it is unlikely that the masks utilized were from the same manufacturing lot.No information indicating a product defect was received.Based on the information available the probable root cause does not appear to be related to a manufacturing defect, or product malfunction.The mask(s) in question were not returned for evaluation nor were the lot numbers provided to assist in confirmation of the root cause.Over-stretched: the mask(s) were not returned for evaluation, however, no information was received indicating that the masks visually appeared to be over-stretched.In addition, the ifu states to replace the eyemax2 with a new one if it becomes over-stretched.The mask(s) in question were not returned for evaluation to assist in confirmation of the root cause, however, the use of an over-stretched mask would be indicative of a use error based on the ifu.Use error - based on the ifu the patient's occipital frontal circumference (ofc) must be measured to determine the correct size of the eyemax2 mask to be used.As the reporting facility did not have a practice in place to document the ofc, we were unable to confirm that the correct size was used.Based on the following the probable cause has been identified as use error: the selection of a mask "too large" may result in slippage.The incidents in question occurred at a single facility.No other related complaints, or adverse reports have been received for the eyemax2 mask in the timeframe identified.Although, the probable root cause was use error based on the investigation , maxtec has conducted a formal review of the eyemax2 risk file considering the adverse event in accordance with iso 14971:2019.A revision of the applicable instructions for use was initiated for improved clarity.

• Brand Name: EYEMAX2 PHOTOTHERAPY MASK
• Type of Device: PHOTOTHERAPY MASK
• Manufacturer (Section D): MAXTEC, LLC; 2305 south 1070 west; salt lake city UT 84119
• Manufacturer Contact: tammy lavery ; 2305 south 1070 west; salt lake city, UT 84119 ; 3855498000
• MDR Report Key: 10856020
• MDR Text Key: 218651940
• Report Number: 1722070-2020-00001
• Device Sequence Number: 1
• Product Code: FOK
• UDI-Device Identifier: 00817770021834
• UDI-Public: 00817770021834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R300P02 PREEMIE EYEMAX2
• Device Catalogue Number: R300P02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A - NOT A REMOVAL.
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 17 DA