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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS; BX20 - PEDIATRIC DISPOSABLE HANDLE 2/BATTERY
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SALTER LABS; BX20 - PEDIATRIC DISPOSABLE HANDLE 2/BATTERY Back to Search Results
Model Number 2016.C
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem Insufficient Information (4580)
Event Date 04/14/2021
Event Type  malfunction  
Manufacturer Narrative
During transport of a patient to the nicu manual ventilation was necessary as the clinician was unable to find the appropriate equipment to intubate.One handle had very dim lighting and another had no light at all.The blades and handles were determined to be the issue for the delayed intubation in a critical situation.Low illumination may delay intubations or increase the number of failed attempts.Standard practice is that a laryngoscope be checked for proper illumination prior intubation.Limited or no illumination could compromise intubation or first pass success rate.
 
Event Description
They had to transport the patient to the nicu manually ventilating so they could find the appropriate equipment to intubate.It was reported that one handle had a very dim light and the other had no light at all.(b)(6), the rt manager at (b)(6), said the products were saved.(b)(6) went through all of the blades and handles and it appears the handles are the issue.Obviously this is a huge concern and we can't go in to a critical situation like this not knowing if the product will work or not.I know (b)(6) just reported another concern last week but it sounds like these 2 instances aren't the only times this was experienced.
 
Manufacturer Narrative
The complaint was confirmed by functional testing.The root cause of the dimness issue is a change in the number of batteries used.The older lot numbers were assembled with two batteries and a spacer, while the newer lot numbers were assembled with three batteries.The two battery configuration was originally used because some physicians complained that the three battery configuration was too bright and could actually reduce visibility.The dimmer light of the two battery configuration was not technically a failure, but was perceived as a defect by physicians comparing the intensity of light using different handles.The two battery configuration also has a shorter battery shelf life, causing some of those handles to stop functioning.Replacement handles assembled with three batteries were sent to the customer to correct the issue.The supplier (conendo surgical) was notified of the complaint via email.Customer follow up explaining the root cause and checking in about the replacement product was conducted via email.Complaint history for this part number was reviewed and this failure mode does not appear to be trending at this time, but will continue to be monitored.The failure mode (r8) reduced or no visualization due to a low or dead battery is identified on the risk analysis file (ra-45) for intubrite single use, green and reusable laryngoscope systems.The severity of harm for this failure mode is considered a moderate (4) risk and does not meet the risk threshold for carb review.
 
Event Description
They had to transport the patient to the nicu manually ventilating so they could find the appropriate equipment to intubate.It was reported that one handle had a very dim light and the other had no light at all.(b)(6), the rt manager at (b)(6), said the products were saved.(b)(6) went through all of the blades and handles and it appears the handles are the issue.Obviously this is a huge concern and we can't go in to a critical situation like this not knowing if the product will work or not.I know (b)(6) just reported another concern last week but it sounds like these 2 instances aren't the only times this was experienced.
 
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Brand Name
SALTER LABS
Type of Device
BX20 - PEDIATRIC DISPOSABLE HANDLE 2/BATTERY
MDR Report Key11756407
MDR Text Key250635819
Report Number3000219639-2021-00007
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2016.C
Device Catalogue Number2016.C
Device Lot Number2020-05-16-BDPS
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/14/2021
Initial Date FDA Received04/30/2021
Supplement Dates Manufacturer Received04/14/2021
Supplement Dates FDA Received05/27/2021
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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