MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. PRECEDENCE SPECT/CT IMAGING SYSTEM; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number 2169-3002A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that during a clinical acquisition, the patient moved their arm into the path of detector 1.The patient's arm became stuck under the arm of detector 1.The philips field service engineer (fse) confirmed there was no harm to the patient.However, there is potential for injury to the patient.This issue has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

Note: follow-up 2 submitted to remove incorrect device code submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

The customer reported that during a clinical acquisition, the patient moved their arm into the path of detector 1 and the patient's arm became stuck under the arm of detector 1.The operator noticed this immediately and manually activated the emergency stop (e-stop) to halt all system motion.The philips product support manager (psm) confirmed there was no malfunction associated with a collision notification not occurring.The patient was removed from the system and evaluated by an onsite doctor and confirmed there was no injury to the patient.The philips field service engineer (fse) visually inspected the system and tested all collision pads.The fse confirmed that all of the collision pads including the detector covers were functioning as specified.Conclusion from the investigation determined that there was no malfunction that occurred, the system was working per design, however, a potential hazard for personal injury was identified.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: PRECEDENCE SPECT/CT IMAGING SYSTEM
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 8151165
• MDR Text Key: 130050070
• Report Number: 1525965-2018-00424
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K041218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2169-3002A
• Device Catalogue Number: 882351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1