FDA Adverse Event Malfunction Summary report: N

PRECSION MEDICAL INC.

MDR report key: 3381555 · Received September 4, 2013

Report

Report Number
2523148-2013-00004
Event Type
Malfunction
Date Received
September 4, 2013
Date of Event
August 14, 2013
Report Date
September 4, 2013
Manufacturer
PRECISION MEDICAL INC.
Product Code
NFB
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

REPORTED THAT THERE WAS A FIRE WITH A CONSERVER. NO REPORTABLE INJURIES, BUT FIRE AND SMOKING DAMAGE, TO DWELLING. PHOTOS OF CONSERVER WERE SENT, SHOWING FIRE DAMAGE, BUT THE CONSERVER AND TANKS HAVE NOT BEEN INSPECTED BY US.

Description of Event or Problem · 1

FIRE INVOLVING A OXYGEN CONSERVER AND OXYGEN TANKS. PATIENT (B)(6) WAS SLIGHTLY INJURED, DID NOT REQUIRE MEDICAL ATTENTION. TRAILER HAD FIRE AND SMOKE DAMAGE. AT THIS TIME UNKNOWN CAUSE FOR THE FIRE, EVIDENCE INDICATES POSSIBLE SMOKING BY PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
439353 PRECSION MEDICAL INC. OXYGEN CONSERVER NFB PRECISION MEDICAL INC. EP5 NA

Patients

Seq Age Sex Outcome Treatment
1 UNK Required Intervention