MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. INGENUITY CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Catalog Number III

Device Problems Device Alarm System (1012); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Note: 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

In this case, the customer reported that the charger had failed on the uninterruptable power supply (ups) causing an alarm to sound.A philips field service engineer (fse) confirmed there was no harm to a patient, operator, or bystander.The fse reported that there was battery acid leakage from the ups batteries.The fse replaced the ups to resolve the issue.

Manufacturer Narrative

On (b)(6) 2015 the customer reported that the charger had failed on the console uninterruptible power supply (ups) causing an alarm to sound.A philips field service engineer (fse) confirmed there was no harm to a patient, operator, or bystander.The philips fse stated that there were no log files pulled as a result of this event as well as the defective console ups was scrapped after this event occurred.The philips fse stated that the failed console ups was the original unit that was installed with the ct system and it was 3 years old at the time of this event.The console ups was replaced and the system is operating as intended.Ct engineering determined this issue to be an acceptable risk.-the system shall only utilize batteries approved by a recognized electrical safety organization (i.E.Ul, csa).-ups owner¿s manual states no user serviceable parts and requires no routine maintenance.-full system ups has temperature sensor monitoring the battery cabinet temperature.-ups comes with status notification (beep alarm for fault condition).-service and user documentation shall identify appropriate personal protective equipment (ppe) and neutralizing agents (ammonia or baking soda).-site planning document recommends to not allow ups closer than 1.5m (60 inches) from patient couch unless it is certified as a medical grade device and/or approved with the ct system.-site planning document recommends that a ups battery cabinet should not be exposed to prolonged periods of temperature above 25 c (77 f).The probable cause based upon the information available is due to defective batteries in the console ups was due to the batteries being 3 years old and needed to be replaced.

• Brand Name: INGENUITY CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: nancy drake ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 5087057
• MDR Text Key: 26426012
• Report Number: 1525965-2015-00247
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033326
• 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: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: III
• 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: 08/27/2015
• 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