MAUDE Adverse Event Report: DIGIRAD CORPORATION ERGO IMAGING SYSTEM; CAMERA, SCINTILLATION (GAMMA)

Device Problem Device Fell (4014)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device was repaired by digirad technician before continued use.Service bulletin 127285 instructions, retrofit kit 54, ergo collimator latch plunger inspection and/or replacement was released 2021-05-19 to provide additional instructions to end users regarding maintenance of the device.Investigation was completed and documented under capa system, (b)(4).

Event Description

Customer stated that the collimator fell off of a head and hit a nuc tech foot after a "student" installed it.Broken foot injury to the technician.Patient followed up with occupational health services.

• Brand Name: ERGO IMAGING SYSTEM
• Type of Device: CAMERA, SCINTILLATION (GAMMA)
• Manufacturer (Section D): DIGIRAD CORPORATION; 13100 gregg street; suite a; poway CA 92064
• Manufacturer (Section G): DIGIRAD CORPORATION; 13100 gregg street; suite a; poway CA 92064
• Manufacturer Contact: elizabeth crawford ; 13100 gregg street; suite a; poway, CA 92064 ; 6197437858
• MDR Report Key: 14438297
• MDR Text Key: 300276459
• Report Number: 2031050-2021-00001
• Device Sequence Number: 1
• Product Code: IYX
• UDI-Device Identifier: 00850816007003
• UDI-Public: (01)00850816007003(11)170208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/05/2021

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male