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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL PED, 40" TUBE RESVR, PED MASK PED, 40" TUBE RESVR, PED MASK, MANO, P/O VALVE, 10' O2 TBG

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VYAIRE MEDICAL PED, 40" TUBE RESVR, PED MASK PED, 40" TUBE RESVR, PED MASK, MANO, P/O VALVE, 10' O2 TBG Back to Search Results
Catalog Number 2K8008
Device Problem Blocked Connection (2888)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). At this time, vyaire has not received the suspect device/component for evaluation.
 
Event Description
Customer reported: child had neuro event where he/she forgot to breath. On 5 liter of o2 on tank and increased to 8 liters. Nurse was alerted to this issue when she noticed there was no airflow through bag. Nurse reported there was no patient harm or injury.
 
Manufacturer Narrative
(b)(4). Device evaluation: the vyaire medical quality team received the suspected device for evaluation. No issues were found. The issue reported by the customer was not confirmed. The root cause of the reported issue could not be confirmed.
 
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Brand NamePED, 40" TUBE RESVR, PED MASK
Type of DevicePED, 40" TUBE RESVR, PED MASK, MANO, P/O VALVE, 10' O2 TBG
Manufacturer (Section D)
VYAIRE MEDICAL
26125 north riverwoods blvd
mettawa IL 60045
Manufacturer (Section G)
PRODUCTOS URÓLOGOS DE MÉXICO S.A. DE C.V.
hilario ruelas 3506 el cóndor
mexicali, b.c., mexico
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 north riverwoods blvd
mettawa, IL 60045
8727570116
MDR Report Key7724481
MDR Text Key115195707
Report Number8030673-2018-00002
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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