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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. HANDSET ALTERA; NEBULIZER (DIRECT PATIENT INTERFACE)
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PARI RESPIRATORY EQUIPMENT, INC. HANDSET ALTERA; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Spontaneous contact: patient's wife reported the cord for the device is broken.The patient did have the defective cord and a replacement has been sent.No adverse events reported due to the defective cord.No other information provided.Indication = cystic fibrosis with pulmonary manifestations.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
HANDSET ALTERA
Type of Device
NEBULIZER (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
PARI RESPIRATORY EQUIPMENT, INC.
MDR Report Key10194839
MDR Text Key196659425
Report NumberMW5095212
Device Sequence Number1
Product Code CAF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
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