FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 146 · Received January 28, 1992

Report

Report Number: 146
Event Type: Injury
Date Received: January 28, 1992
Date of Event: December 20, 1991
Report Date: December 30, 1991
Manufacturer: UNKNOWN
Product Code: FMT
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

THIRTY-WEEK INFANT PLACED ON RADIANT WARMER TABLE. LAMPS POSITIONED 19 INCHES FROM INFANT. AFTER EIGHT MINUTES, INFANT NOTICED TO HAVE FIRST-DEGREE BURNS ON LEFT CHEST, ABDOMEN, AND LEFT ARM AND LEFT LEGINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, INVALID DATA. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA, INVALID DATA. CONCLUSION: INVALID DATA, DEVICE FAILED JUST PRIOR TO USE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN		FMT	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	7 MO		Required Intervention