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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. WISP YOUTH NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS RESPIRONICS, INC. WISP YOUTH NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problems Inaccurate Flow Rate (1249); Nonstandard Device (1420); Device Damaged by Another Device (2915)
Patient Problems Dyspnea (1816); Headache (1880); Sleep Dysfunction (2517)
Event Date 11/14/2022
Event Type  Injury  
Event Description
(b)(6) is a 12 yo male.He is non-verbal.Something was bothering him and we could not figure it out.(b)(6) has hydrocephalus with a vp shunt.The rt informed us that the mask was recalled due to the magnetic device potentially causing harmful side effects.After further a valuation, it was determined that the youth wisp nasal mask change (b)(6) vp shunt shutting causing his csf fluid to drain at a faster rate causing low pressure headaches.The pain was so intolerable it caused diminished breathing, inability to sit-up and sleeping excessively.
 
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Brand Name
WISP YOUTH NASAL MASK
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS RESPIRONICS, INC.
MDR Report Key16043167
MDR Text Key306205924
Report NumberMW5113965
Device Sequence Number1
Product Code OJG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 12/06/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Treatment
9% SALINE; BETHKIS; CALCIUM; CAYSTON; DIAMOX; HILL ROM VEST; HYPERTONIC SALINE; KEPPRA; LEVOCARNITINE; MIRALAX; NEBULIZER MACHINE; PULMOZYME; SIMETHICONE DROPS; SOTALOL; SUCTIONER; TRILOGY EVO AVAP; VITAMIN D; XOPONEX
Patient Outcome(s) Hospitalization;
Patient Age12 YR
Patient SexMale
Patient Weight39 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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