MalfunctionHSS

STAT MEDICAL

Received Oct 16, 1998 · Event occurred Oct 13, 1998

Report 192284 · MDR key 192284

Device

Generic name

Head Halter

Manufacturer

Stat Medical Division Of Deroyal Ind.

Model number

9223-00

Catalog number

Lot number

454793

Product problems

Thermal Decomposition of Device
Smoking

Patient

45 YR

Burn(s)
Surgical procedure, delayed

Narrative

Description of Event or Problem

THE PT WAS HAVING A NEURO PROCEDURE (LEFT SIDE OF NECK). AS THE PROCEDURE BEGAN SMOKE WAS SEEN COMING OUT FROM UNDER THE LEFT SIDE OF THE DRAPE. DRAPES WERE REMOVED AND THE PT'S HEAD HALTER WAS SMOKING/BURNING. AREA WAS DOUSED WITH SALINE SOLUTION. THE HEAD HALTER WAS REMOVED REVEALING BURN MARKS TO THE LEFT SIDE OF THE NECK AND EAR. THE PROCEDURE WAS LATER CONTINUED.