MAUDE Adverse Event Report: CARESTREAM HEALTH INC DIRECTVIEW 9500 SYSTEM; DR 9500

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

This report failed due to an error and resubmitted on 09/13/2017 as an initial report.Carestream is currently investigating this event.Another update will be submitted when more information is available.

Event Description

A plastic cover on the dr 9500 fell off of the device and made contact with the leg of a child and the technologist.There was no injury.

Manufacturer Narrative

The investigation found that the cover was damaged due to this specific site using an unusual protocol/configuration that is not used anywhere else.This resulted in the cover being damaged.The site did not have it repaired and left it in use.This resulted in the cover detaching and falling off.Per european regulations, the site is responsible for taking a device out of service, csh (or authorized rep) cannot do this.That is why this device was left in service, causing the cover to fall off.There is no further action required by carestream health.

Event Description

A plastic cover on the dr 9500 fell off of the device and made contact with the leg of a child and the technologist.There was no injury.

• Brand Name: DIRECTVIEW 9500 SYSTEM
• Type of Device: DR 9500
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC; 1049 ridge road west; rochester NY 14615
• Manufacturer Contact: michael callery ; 150 verona st; rochester, NY 14608
• MDR Report Key: 6862450
• MDR Text Key: 86100734
• Report Number: 1317307-2017-00014
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1