FDA Adverse Event Malfunction Summary report: N

CINE CAMERA - ARRITECHNO CAMERA

MDR report key: 3593 · Received December 30, 1992

Report

Report Number: 3593
Event Type: Malfunction
Date Received: December 30, 1992
Date of Event: October 7, 1992
Report Date: October 8, 1992
Manufacturer: SIEMENS MEDICAL SYSTEMS, INC.
Product Code: IZJ
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

CINE CAMERA FELL FROM MOUNT STRIKING PATIENT'S RIGHT FOREARM. THE PATIENT SUFFERED NO FURTHER UNTOWARD EFFECTS. AN X-RAY OF THE PATIENT'S RIGHT FOREARM WAS NEGATIVE. SAFETY CABLE SLIPPED FROM MOUNT FLANGE AND FAILED TO PREVENT CAMERA FROM FALLING. SIEMENS FIELD SERVICE REPORT ATTACHEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, MATERIAL DEGRADATION/DETERIORATION, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		CINE CAMERA - ARRITECHNO CAMERA	IZJ	SIEMENS MEDICAL SYSTEMS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Other