FDA.reportPublic FDA data

MAUDE MDR 5855494

MDR report key
5855494
Report number
2020676-2016-00005
Event key
0
Event type
3
Date of event
2015-08-22
Date received
2016-08-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. VICTOR ARELLANO
Address
4225 E. LA PALMA AVENUE ANAHEIM CA 92807 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYPERBARIC CHAMBERHYPERBARIC CHAMBERSECHRIST INDUSTRIES, INC.CBF2500B/BRN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-0801. D

Event Narratives#

N

Patient 1

SECHRIST MADE SEVERAL ATTEMPTS TO TRY AND OBTAIN THE CHAMBER FOR EVALUATION. SEVERAL PHONE CALLS WERE MADE TO DR. (B)(6) AT (B)(6) AND MESSAGES WERE NEVER RETURNED. BASED ON DEVICE HISTORY REVIEW, THIS CHAMBER WAS IN USE BEYOND THE CURRENT PVHO REGULATED CYLINDER LIFE OF 20 YEARS AND WAS MANUFACTURED IN 1989. THIS HYPERBARIC CHAMBER WAS ORIGINALLY SOLD TO (B)(6) HOSPITAL AND SECHRIST CONDUCTED ANNUAL PREVENTATIVE MAINTENANCE THROUGH 1998. AT NO TIME WAS SECHRIST MADE AWARE OF RELOCATION OF THIS CHAMBER TO ANY OTHER FACILITY. (B)(6) FIRE INVESTIGATION STATED THAT DR. (B)(6) PURCHASED THE CHAMBER ON (B)(6). BASED ON (B)(6) FIRE INVESTIGATIONS SECHRIST INDUSTRIES ALSO LEARNED THAT DR. (B)(6) PLACED A BATTERY OPERATED FAN IN THE CHAMBER WHILE IN USE. INTRODUCTION OF ANY TYPE OF HEAT SOURCE INTO A HYPERBARIC CHAMBER IS STRICTLY AGAINST MANUFACTURER RECOMMENDATIONS AS WELL AS NFPA99 HEALTH CARE FACILITIES CODE, CHAPTER 14 HYPERBARIC FACILITIES. : DEVICE NOT PROVIDED FOR EVALUATION.

D

Patient 1

SECHRIST INDUSTRIES RECEIVED AN EMAIL FROM (B)(6) WITH (B)(6) NEWS STATING THAT THEY WOULD BE AIRING A STORY ABOUT A FIRE THAT TOOK PLACE INSIDE A HYPERBARIC CHAMBER AT (B)(6). REPORTEDLY, (B)(6) BROUGHT HER DOG TO THE VETERINARIAN CLINIC WHERE DR. (B)(6) GAVE THE DOG OXYGEN THERAPY BY PUTTING THE DOG INSIDE A HYPERBARIC CHAMBER. DURING THERAPY THE CHAMBER CAUGHT ON FIRE, KILLING THE DOG.