MAUDE Adverse Event Report: ARCOMA AB 0180 INTUITION AND 0072 PRECISION STATIONARY DIGITAL X-RAY SYSTEMS; STATIONARY X-RAY SYSTEM

Model Number 0072

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

During installation of the device it was noticed that spring channels nuts with the wrong dimension was delivered with the system.Investigation shows that our supplier of spring channel nuts has delivered a batch with a thinner material than specified.Supplier is informed and actions to prevent further incorrect deliveries are taken.Several load test has been performed and the incorrect nut holds the specified load multiplied with four and is consider safe to use, no corrective action in field is needed.All affected systems has been delivered within europe and asia.

Event Description

During installation of the device it was noticed that spring channel nuts with wrong dimensions was delivered with the system.

• Brand Name: 0180 INTUITION AND 0072 PRECISION STATIONARY DIGITAL X-RAY SYSTEMS
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): ARCOMA AB; annavägen 1; växjö, 35246 ; SW 35246
• Manufacturer (Section G): ARCOMA AB; annavägen 1; växjö, 35246 ; SW 35246
• Manufacturer Contact: elisabeth lundahl ; annavägen 1; växjö, 35246 ; SW 35246 ; 470706952
• MDR Report Key: 5540598
• MDR Text Key: 41614195
• Report Number: 9616014-2016-00001
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: 0072
• Device Catalogue Number: 0072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial