MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. PROTEUS XR/A; SYSTEM, X-RAY, STATIONARY

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Installation-Related Problem (2965)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2017, the technologist at (b)(6) healthcare in the united states stated that during a wall stand radiographic exam the collimator detached from the tube column.The technologist caught the collimator from falling and therefore the collimator did not impact any person.There was no injury related to this event.

Manufacturer Narrative

Ge healthcare¿s investigation has been completed and the root cause of the collimator detaching was the ge field engineer (fe) did not properly install the collimator.The day prior to the collimator detaching, the fe confirmed the collimator was de-installed/re-installed as a result of an x-ray tube replacement.The instructions within the service manual contain the following caution ¿the collimator rotation lever must be fully depressed when mounting/installing the collimator to the tube/collimator interface plate.Failure to do so could cause the collimator to mount improperly and fall from the unit.¿ this caution was reviewed with the fe and he confirmed he did not depress the rotation lever when he installed the collimator the previous day.To correct this issue, the fe installed the collimator according to the most current revision of the service manual and was reminded to always follow all instructions, warnings and cautions within all system documents.No further actions are needed.

• Brand Name: PROTEUS XR/A
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; no.1 yongchang north road; beijing economic and technolog; beijing ; CH
• Manufacturer Contact: anne krueger ; 3000 north grandview boulevard; waukesha, WI
• MDR Report Key: 6725995
• MDR Text Key: 80627927
• Report Number: 9613445-2017-00001
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 68