MAUDE Adverse Event Report: VYAIRE MEDICAL, INC BLADE, LARYN, VS, PLASTIC, MIL 1; LARYNGOSCOPE, RIGID

Catalog Number 4511

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoxia (1918)

Event Date 05/14/2017

Event Type  Injury  

Manufacturer Narrative

Vyaire has received the complaint device and is currently performing an investigation into the reported issue.A follow up mdr will be sent once the investigation has been completed.(b)(4).

Event Description

The customer reported that the end user "found it was hard to him to get a clear view due to reflections.The baby was hypoxic, needed intubation, the user found it hard to get a clear view due to reflections.When the specialist nurse intubated the baby the nurse had the appearance of inappropriate light during the intubation procedure.It was an event where the intubation was seen as very important to secure the airway.A cardiac arrest on a child in 3 months of age, likely caused by aspiration with probable floating tube feed in the airways.Respiratory protection was conducted with leaders and intubation without transparency, with good results.The task was solved on alternative adequately.The nurse used a boogie leader to insert the et-tube.During the ambulance transport to hospital the baby had a regular ecg heartbeat rhythm".

Manufacturer Narrative

An open sample was received the reported product codes, and a complete inspection was performed no issues were found.In addition the blade was assembled with a laryngoscope and it turned on properly.Therefore the reported issue cannot be confirmed.No corrective actions will be implemented.

• Brand Name: BLADE, LARYN, VS, PLASTIC, MIL 1
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VYAIRE MEDICAL, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 6768764
• MDR Text Key: 81900886
• Report Number: 8030673-2017-00358
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO