MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 64

Model Number 728231

Device Problems Leak/Splash (1354); Battery Problem (2885); Chemical Spillage (2894); Temperature Problem (3022)

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

Event Type  malfunction  

Event Description

The customer reported that the ups was warmer than normal.The philips field service engineer determined that the batteries had leaked acid and a small amount of it had exited a gap in the case.There was no burning smell, smoke or fire.The fse replaced the ups and battery cabinets.The batteries were disposed of as industrial waste.The fse confirmed that there was no harm to a patient, operator, or bystander due to this issue.

Manufacturer Narrative

(b)(4).On (b)(6) 2013 the customer at (b)(6) reported that the ups was warmer than usual when the br 64 system was not in clinical use.There was no report of smoke or fire with this event.There was no injury to patient, operator or bystander with this issue.Upon further investigation of the contents of the ups cabinet by the fse, there was battery acid leakage which was visible on the outside of the ups battery case.The philips fse investigated the issue and determined that the console ups external battery pack (battery, ups, 3.5 kw) had failed and leaked battery acid outside of the external battery case.The external battery and ups controller was removed from the system and was returned to philips for a root cause investigation.The customer did not use the system until a replacement ups and external battery pack was installed.The replacement ups and external battery pack was installed on (b)(4) 2013 and the system was operating as intended.The failed components sent back to the supplier for a failure analysis to be performed.A field failure analysis report was provided by the supplier regarding the failed ups and external battery pack.Swollen batteries are due to "gassing." gassing occurs when the liquid inside the battery converts to hydrogen and oxygen gas.Gassing can occur due to the following issues: overcharging the battery - the ups, (b)(4) had proper charging function so overcharging can be eliminated as the cause.High temperature - this was most likely the cause of the swollen batteries.As the batteries get older, their ability to recombine the hydrogen and oxygen gas to the sulfur is reduced.This reduced ability causes an increase in the battery temperature and the gas to build up and swell or crack the battery case.No new corrective actions will be implemented.(b)(4).The batteries performed sufficiently.Batteries are consumable parts with a limited lifetime and require periodic replacement.The overall risk is based on engineer's investigation and according to the risk assessment this reported event was determined to be of acceptable risk: the system shall only utilize batteries approved by a recognized electrical safety organization ((b)(4)).Full system ups has temperature sensor monitoring the battery cabinet temperature.Ups comes with status notification (beep alarm for fault condition).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 root cause of the failed battery pack was that it was 4 years 9 months old which exceeds (b)(4) recommendations of battery life; philips does not support preventive maintenance and proactive battery replacement to prevent these types of failure from occurring.High temperature was most likely the cause of the swollen batteries.As the batteries get older, their ability to recombine the hydrogen and oxygen gas to the sulfur is reduced.This reduced ability causes an increase in the battery temperature and the gas to build up and swell or crack the battery case.On (b)(6) 2013 the customer at (b)(6) discontinued use of their br 64 system at the time of the ups battery failure.The philips fse arrived on site the same day and remove the failed components from the site.On (b)(4) 2013 the philips fse installed a replacement console ups and external battery pack.(b)(4).

• Brand Name: BRILLIANCE 64
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd.; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 4241243
• MDR Text Key: 5066603
• Report Number: 1525965-2014-00155
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728231
• Device Catalogue Number: NCTB423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1