MAUDE Adverse Event Report: GENERAL MEDICAL MERATE S.P.A. PRECISION RXI; PRECISION RXI ANALOG X-RAY SYSTEM

Device Problems Device Damaged Prior to Use (2284); Human Factors Issue (2948); Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturers investigation has completed and the root cause of the event was determined to be use error as the customer should instruct the patient to use the table hand grips.The customer was also knowingly using the device with a damaged mylar guard.

Event Description

On (b)(6)2017, the radiologist at (b)(6) reported that during a barium swallow exam as the radiologist commanded the table to move horizontally, a patient was injured.The patient was holding onto the tabletop edges during this table movement and their left-hand finger was caught on the mylar guard located underneath the tabletop edge.When the patient quickly removed their finger, their finger was lacerated by the mylar guard.The patient received a laceration on their left hand forth digit that required six stitches.This complaint was received on a precision rx/i system which is imported/distributed, but is not manufactured by (b)(4).The manufacturer of the precision xr/i is general medical (b)(4).

• Brand Name: PRECISION RXI
• Type of Device: PRECISION RXI ANALOG X-RAY SYSTEM
• Manufacturer (Section D): GENERAL MEDICAL MERATE S.P.A.; via partigiani 25; seriate, bg ; IT
• Manufacturer Contact: anne krueger ; 3000 north grandview boulevard; waukesha, WI
• MDR Report Key: 6805606
• MDR Text Key: 83098223
• Report Number: 2126677-2017-00011
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K041605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2017
• Distributor Facility Aware Date: 07/31/2017
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2017
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2006
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 91