MAUDE Adverse Event Report: BIO-MEDICAL DEVICES, INC. MAXAIR; GOWN, SURGICAL

Model Number 2080-03

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2020

Event Type  malfunction  

Event Description

Maxair capr helmet are used as personal protective equipment (ppe) at the hospital.The capr helmets are commonly used in all patient rooms that are classified with highly communicable diseases such as covid-19, as well as any patient's under investigation (pui) for covid-19.The biomedical engineering deployed fleets of new maxair capr helmets to departments as part of ppe supplies for clinical staff.These were first seen in our pediatric intensive care unit picu, surgical care unit, and emergency department since these areas were set up as the response units for covid-19 admissions and treatment.With a week span, biomedical engineering received 10 repair calls for broken power cables on these new capr helmets.This poses several issues for the departments and their clinical staff.Some of these issues are: (1) staff members using the helmets in admitted patient rooms experienced permanent or intermittent power outages on the helmet, leaving them exposed with out proper ventilation from the powered fan built into the capr helmet, (2) furthering ppe shortages for clinical staff while they waited for power cables to be ordered and replaced, which in turn poses potential risk to staff members and patient safety.Biomedical engineering conducted an investigation into the helmets and their power cables to determine reasons for why many were continuously breaking in a short period of time.It was seen that the power cable undergoes a consistent bending stress at the right angled connection located on the helmet.One scenario that could lead to this was that clinical staff was sometimes placing the rechargeable battery pack on the left hip, since they interpreted maxair recommendations as preferential to the end user.The manufacturer recommended that the battery pack is placed on the right hip.When the battery pack was placed on the left hip, the maxair right angled power cable did a bend, causing stress on the material and breakage.Biomedical engineering contacted the manufacturer to report these early breakages, and to have an on-site visit by the manufacturer to confirm information gathered through our investigation.The manufacturer agreed with our investigation results, but offered no solution to securing the cable so that it could only be routed to the right side of the helmet from its left sided connector.In response, biomedical engineering proposed a cable securing plan to the manufacturer and end users.The manufacturer confirmed that the solution would not impact device safety or device use since the solution was superficial to any working components.Our goal was to direct and guide the cable to the right side of the helmet to reduce any stress and strain on the connector material.In turn, this would also encourage clinical users to wear the battery pack on the manufacturer recommended right hip.Four small holes would be cut into the clear plastic inner lining of the helmet ¿ two pairs on either side of the upper cap clip on the rear of the capr.Then, two small zip ties would loop through these holes in the inner plastic lining, securing around the right angled power cable.The power cable would then appropriately be routed from the left sided helmet connector to the right side of the users body.After confirmation from the manufacturer and initial testing/approval by the clinical departments, biomedical engineering began deploying this cable securing solution to all capr helmets that were purchased and deployed to units.Immediately, biomedical engineering saw a decrease in any power cable related calls on the maxair capr helmets at the hospital.

• Brand Name: MAXAIR
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): BIO-MEDICAL DEVICES, INC.; 17171 daimler street; irvine CA 92614
• MDR Report Key: 14736351
• MDR Text Key: 294383814
• Report Number: 14736351
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2080-03
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1