MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRIGHTVIEW GAMMA CAMERA SYSTEM

Model Number 2170-3000A

Device Problems Break (1069); Detachment Of Device Component (1104); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).

Event Description

The customer heard a loud popping and grinding noise during radius motion with the brightview spect camera system.This caused foller errors which resulted in a node going off line.The brightview spect camera system was not in clinical use while awaiting service.The field service engineer (fse) determined the brake key on the radius drive gear box had been sheared off, which appeared to be a malfunction in the mechanical drive assembly of the detectors.The exact cause of this malfunction was not able to be determined by the fse.The defective parts were ordered and replaced.The system was restored to clinical use.There was no report of harm to patient, operator or bystander.New information received through systems engineering has determined that if the gearbox shaft key becomes disengaged due to the snap ring not being included or the gearbox shaft key is missing, the brake system could be rendered ineffective for the tangential or radius drive assemblies for the detectors.Therefore this has been determined to be a reportable event.

Manufacturer Narrative

The customer reported hearing a loud popping and grinding noise during radius motion with the brightview spect camera system.The field service engineer (fse) confirmed there was no report of harm to a patient, operator or bystander.The fse determined the brake key on the radius drive gear box had been sheared off, which appeared to be a malfunction in the mechanical drive assembly of the detectors.The fse replaced the radius lead screw swap, radius gear box swap, and the radius safety plate.Field change order (b)(4) was initiated and field safety notice (fsn) cle17-006_88200502_88200503 rev 01 was released 24-feb-2017.The system is in clinical use.

• Brand Name: BRIGHTVIEW GAMMA CAMERA SYSTEM
• Type of Device: GAMMA CAMERA SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: chris smith ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 6376289
• MDR Text Key: 69267636
• Report Number: 1525965-2017-00005
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2170-3000A
• Device Catalogue Number: 882480
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1525965-03-09-17-004-C
• Patient Sequence Number: 1