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

Model Number 2160-3000A

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

In this case, the customer reported that when contacting the touchscreen to request a pre-programmed motion (ppm), the touchscreen fell forward but remained attached to the boom assembly by the signal cable and power cables.There was no report of harm to a patient, operator or bystander.The philips field service engineer (fse) evaluated the system and determined the four screws that hold the touchscreen to the mounting plate were missing.The screws were recovered and the fse replaced the missing screws and attached the touchscreen to the mounting plate to resolve the issue.

Manufacturer Narrative

On (b)(6)-2015, the customer stated that when contacting the touchscreen to request a pre programmed motion (ppm), the touchscreen fell forward but remained attached to the boom assembly by the signal cable and power cables.There was no report of harm to a patient, operator or bystander as a result of this event.The philips field service engineer (fse) was contacted and it was communicated that the touchscreen monitor fell from its mounting plate due to all 4 mounting screws backing out.The fse stated that when he arrived onsite to investigate the issue, he found a couple of the mounting screws on the floor.The philips fse replaced all four of the mounting screws to resolve the reported issue.The fse also stated that the system was installed for approximately 10 years.The skylight installation manual states: "using four screws, attach the monitor to the ergotron monitor mount; tighten until secure." there is no specification for loctite or any torque specs referenced in this manual.Based upon the information provided by the fse, the probable cause of this event was due to all 4 mounting screws becoming loose over time.

• Brand Name: SKYLIGHT IMAGING SYSTEM
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: nancy drake ; 595 miner rd; mr training department; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 5104017
• MDR Text Key: 26962582
• Report Number: 1525965-2015-00257
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2160-3000A
• Device Catalogue Number: 882050
• 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
• Date Manufacturer Received: 08/25/2015
• 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: N/A
• Patient Sequence Number: 1