BROSELOW RESUSCITATION MODULES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-23 for BROSELOW RESUSCITATION MODULES manufactured by Armstrong Medical.

Event Text Entries

[49195512] I am a physician-researcher working to improve the safety of pediatric patients in general hospital settings (specifically eds). Our work leverages simulation to describe, measure and improve care in those settings. In reviewing our data we have uncovered a device/systems based latent safety threat that has the potential to lead to harm. I have described that threat in detail below. Situation: there is a recurrent latent safety threat that we have noted in eds using the broselow pediatric emergency system intubation modules with plastic/disposable blades in each drawer. Ed providers attempt to use these blades with their standard stock handles and these lack interoperability (they need to use the broselow blue handle). These intubation handles are not stocked in each drawer. When the provider needs a handle for the blade in the package they are often given/grab one from their standard ed supply (instead of using the broselow handle in the cart). Background: the broselow system comes pre-stocked with equipment modules for each patient weight/color that include disposable blades in each drawer and a two blue laryngoscope handles that are intended to be used for all handles. Assessment: this safety threat has resulted in significant delays in time critical intubations and/or inability to intubate during simulated pediatric resuscitations across 20 general eds. During simulations the provider teams do not recognize this lack of interoperability. Teams have replaced batteries and called for "back-up" airways teams resulting in delays in care (we can\ let this evolve as it is a simulated patient with no risk for harm). Plan: explore how to best communicate this threat to end-users and improve clarity on lack of interoperability. Potential solution: in eds we have worked with some have mitigated this threat by including the appropriate size standard sock non-disposable blades in each drawer. Other eds have placed a handle in each drawer and clearly marked on the packaging need to use the blue handle. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5063096
• MDR Report Key: 5754578
• Date Received: 2016-06-23
• Date of Report: 2016-06-23
• Date of Event: 2016-06-23
• Date Added to Maude: 2016-06-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BROSELOW RESUSCITATION MODULES
• Generic Name: BROSELOW
• Product Code: CAL
• Date Received: 2016-06-23
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARMSTRONG MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-06-23