MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING DISCOVERY NM/CT 670; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number DISCOVERY NM/CT 670

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Event Description

Two nurses rolled a patient bed into a nuclear medicine room.In an attempt to raise the bed to the level of the nuclear medicine bed, a part of the bed raised up into the camera cover, causing damage to the cover of the camera.The area around the camera is limited.The bed is large and takes up much of the space.There is a lack of space to properly see around the bed while it is being raised.Because of this, the nurses did not realize the bed was rising into the cover.Ge came out to inspect the camera and damage was limited to the cover.The ge tech stated that they see this happen all the time.No harm to patient or staff, but the potential is there.The question was raised, "if it happens so often, why doesn't ge put a sensor on the camera when it senses the stress on the cover?" manufacturer response for nuclear medicine gamma camera, discovery 670 gamma camera (per site reporter).They came out to verify that the ge camera functioned properly and safely.They will be ordering a new cover.

• Brand Name: DISCOVERY NM/CT 670
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; 3000 n. grandview blvd.; waukesha WI 53188
• MDR Report Key: 8508292
• MDR Text Key: 141761447
• Report Number: 8508292
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/05/2019,03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISCOVERY NM/CT 670
• 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: 04/05/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1