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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD I NEB; MESH NEBULIZER
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RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD I NEB; MESH NEBULIZER Back to Search Results
Model Number 85-149
Device Problem Infusion or Flow Problem (2964)
Patient Problem Respiratory Distress (2045)
Event Date 01/07/2018
Event Type  Injury  
Event Description
It was reported that the patient believed this device had something wrong and the treatment times were increasing.It was also reported that the patient presented to hospital and was admitted.(b)(4).
 
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Brand Name
I NEB
Type of Device
MESH NEBULIZER
Manufacturer (Section D)
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
chichester business park
city fields way, tangmere
chichester, west sussex PO20 2FT
UK  PO20 2FT
Manufacturer Contact
alessandro agosti
chichester business park
city fields way, tangmere
chichester, west sussex PO20 -2FT
UK   PO20 2FT
MDR Report Key7296252
MDR Text Key100924652
Report Number9681154-2018-00006
Device Sequence Number1
Product Code CAF
UDI-Device Identifier00383730000978
UDI-Public00383730000978
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number85-149
Device Catalogue Number85-167
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
VENTAVIS
Patient Outcome(s) Hospitalization;
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