EPK-I5010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for EPK-I5010 manufactured by Pentax Of America, Inc..

Event Text Entries

[135859995] The pentax epk-i5010 endoscopy light source and digital recorder, when directly connected to a hospital communication network, is susceptible to malware infection resulting from eternalblue/wannacry attacks. This is a result of device internal software ((b)(6) embedded) not being patched to protect against this vulnerability. It is not possible for end users to patch this software themselves or disable the threat on the device. The hospital has around 12 of these systems. The device is expected to recover from an attack after a reboot by reloading its operating software. If attacked, until it has been rebooted it is able to carry out the design of the malware possibly effecting other systems on the hospital network. This poses a risk to patient care because a system being infected would cause a delay while the system is pulled from service and rebooted. It also poses a threat to other systems on the network which hold patient information. Appropriate mitigation is to use a firewall to block communication with the epk-i5010 on port 445. Manufacturer response for video processor, epki-5010 (per site reporter). Pentax has been made aware of this vulnerability and is reported to be devolving an official software patch to eliminate this risk. Their last message to us where they stated they are hoping for a patch to be released in mid-(b)(6) to u. S. Customers.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8330528
• MDR Report Key: 8330528
• Date Received: 2019-02-12
• Date of Report: 2019-02-08
• Date of Event: 2018-11-29
• Report Date: 2019-02-08
• Date Reported to FDA: 2019-02-08
• Date Reported to Mfgr: 2019-02-12
• Date Added to Maude: 2019-02-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EPK-I5010
• Generic Name: ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT
• Product Code: PEA
• Date Received: 2019-02-12
• Model Number: EPK-I5010
• Catalog Number: EPK-I5010
• Device Availability: *
• Device Age: 4 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PENTAX OF AMERICA, INC.
• Manufacturer Address: 3 PARAGON DRIVE MONTVALE NJ 07645 US 07645

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-02-12