FDA Adverse Event Injury Summary report: N

DRAEGER D-VAPOR DESFLURANE VAPORIZER

MDR report key: 1781486 · Received July 26, 2010

Report

Report Number
MW5016839
Event Type
Injury
Date Received
July 26, 2010
Report Date
July 26, 2010
Manufacturer
DRAEGER MEDICAL INC.
Product Code
CAD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

ANESTHESIOLOGIST NOTICED FIRST THING THIS MORNING THAT THE VAPORIZER APPEARED TO HAVE NO POWER AND FELT COLD TO TOUCH. WHEN HE GRABBED THE POWER CORD, THE DEVICE POWER WAS RESTORED MOMENTARILY. HE THEN NOTICED THE POWER CORD AND THE POWER RECEPTACLE WERE CHARRED, AT WHICH TIME HE CALLED THE FACILITY'S ELECTRICIAN. THE POWER PLUG'S NEUTRAL PIN BURNED OFF AND STUCK IN THE POWER RECEPTACLE. THE DEVICE HAD AN ELECTRI-CORD POWER CORD THAT HAS BEEN INVOLVED IN OTHER MANUFACTURER'S RECALLS, BUT NOT BY DRAEGER AS OF YET. PER THE INSTRUCTIONS OF THE VETERANS HEALTH ADMINISTRATION WARNING SYSTEM PT SAFETY ALERT ISSUED FOR ELECTRICORD POWER CORDS, I WILL NOTIFY THE MANUFACTURER TO HAVE THE DEVICE REPAIRED OR REPLACED AS NECESSARY. THIS IS FOLLOW-UP INFO TO PREVIOUSLY ENTERED REPORT. I SUBMITTED A REPORT ON (B)(6) 2010 FOR A DRAEGER M35500 DESFLURANE VAPORIZER (B)(4). I REPORTED, THE PLUG FOR THIS DEVICE AS BEING AN ELECTRI-CORD POWER CORD AS IT LOOKED JUST LIKE ONE AND THE AREA WHERE THE ELECTRI-CORD'S SYMBOL WOULD BE WAS CHARRED. AFTER SPEAKING WITH (B)(4), DRAEGER'S SENIOR QUALITY ASSURANCE MANAGER, I LEARNED THAT IT WAS NOT AN ELECTRI-CORD POWER CORD. I BELIEVE HE SAID THEIR CORDS WERE MANUFACTURED BY FELLER. THE DESIGN FOR THIS POWER CORD'S PLUG IS SIMILAR TO THAT OF ELECTRI-CORD, WHICH PERSUADED ME TO THINK THE CORD WAS MANUFACTURED BY ELECTRI-CORD. THIS LEADS ME TO BELIEVE THAT THE DESIGN IS FLAWED, NOT JUST THE MANUFACTURING PROCESS, AND THAT THIS SHOULD BE A CONSIDERATION IN THE FDA'S INVESTIGATION INTO THE FAULTY POWER CORDS WHICH WERE THE REASON FOR SEVERAL MANUFACTURER'S RECALLS, ALL OF WHICH, TO MY KNOWLEDGE, DEALT ONLY WITH ELECTRI-CORD POWER CORDS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DRAEGER D-VAPOR DESFLURANE VAPORIZER DESFLURANE VAPORIZER CAD DRAEGER MEDICAL INC. M35500-18 NA

Patients

Seq Age Sex Outcome Treatment
1 Disability