HYPERBARIC CHAMBER 31"

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-14 for HYPERBARIC CHAMBER 31" manufactured by Summit To Sea.

Event Text Entries

[102583046] I was sitting inside a hyperbaric chamber from summit to see and the zipper malfunctioned and the chamber popped open with me in it.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075868
MDR Report Key7340835
Date Received2018-03-14
Date of Report2018-03-13
Date of Event2018-02-13
Date Added to Maude2018-03-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHYPERBARIC CHAMBER 31"
Generic NameCHAMBER HYPERBARIC
Product CodeCBF
Date Received2018-03-14
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSUMMIT TO SEA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-14

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