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

Model Number 882446

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

We have not completed our investigation for this event.We will file a follow-up emdr at the completion of the investigation.(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 the patient placed their hand on the edge of the table.Philips field service engineer (fse) confirmed the patient's hand was pinched between the table and upper pallet during a scan topographic exam.This issue has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

20-feb-2019 (b)(6).This record is follow-up 2 with the following edits: type of reportable event: serious injury.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.S.

Manufacturer Narrative

The customer reported that a patient¿s hand was pinched between the table and upper pallet during an exam.During the exam, the patient placed his hand on the edge of the table and as the table moved into position, the patient¿s hand was pinched between the table and upper pallet.The philips field service engineer (fse) confirmed there was no serious injury; this was a pinch only.The fse evaluated the system and confirmed that the system is compliant; there was no system malfunction.The operator instructed the patient not to hold onto the side of the table during the scan.The system is in clinical use.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: VEREOS PET/CT
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 8020792
• MDR Text Key: 125759581
• Report Number: 1525965-2018-00420
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K123599
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 882446
• Device Catalogue Number: 882446
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1