FDA Adverse Event Malfunction Summary report: N

DIGITAL RADIOGRAPHY CXDI

MDR report key: 9508737 · Received December 22, 2019

Report

Report Number: 1000181430-2019-00002
Event Type: Malfunction
Date Received: December 22, 2019
Date of Event: August 21, 2019
Report Date: November 27, 2019
Manufacturer: CANON, INC.
Product Code: MQB
UDI-DI: 04549292049695
PMA / PMN Number: K103591
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT HAPPENED WHEN THE SERVICE PERSON UPDATED THE CONTROL SOFTWARE OF THE X-RAY DETECTORS (CXDI-401C COMPACT/701C WIRELESS). THE SERVICE PERSON DID NOT CONFIRM WHETHER THE CAPTURED IMAGE COULD BE OUTPUT TO PACS SYSTEM NORMALLY AND INSTALLATION ERROR WAS NOT NOTICED, AS A RESULT HE HANDED IT OVER TO THE CUSTOMER WITH INCORRECT INSTALLATION. FROM THE ABOVE, THE CAUSE IS DETERMINED AS AN INSTALLATION ERROR OF THE SERVICE PERSON, AND THE WORK PROCEDURE WILL BE NOTIFIED TO THE SERVICE PERSON ONCE AGAIN. THIS EVENT WILL NOT CAUSE ANY SERIOUS HEALTH HAZARDS TO THE PATIENT. IN ADDITION TO CXDI-401C COMPACT OTHER RELATED DEVICE INFORMATION IS DESCRIBED AS BELOW. ADDITIONAL DEVICE INFORMATION: MODEL NUMBER #: CXDI-701C WIRELESS; CATALOG NUMBER #: 8559B003AF; SERIAL NUMBER #: (B)(4); UDI NUMBER #: (B)(4); PMA/510(K) NUMBER #: K131106. MANUFACTURER CROSS-REFERENCE #:MW5090483.

Description of Event or Problem · 1

AFTER UPDATING THE CONTROL SOFTWARE FOR X-RAY DETECTORS (CXDI-401C COMPACT/701C WIRELESS), THE CAPTURED IMAGE COULD NOT BE SEND TO PACS SYSTEM, AND THEN EVENTUALLY THE IMAGE DISAPPEARED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1303554	DIGITAL RADIOGRAPHY CXDI	X-RAY DIGITAL RADIOGRAPHY	MQB	CANON, INC.	CXDI-401C COMPACT	N/A	04549292049695

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR