MAUDE Adverse Event Report: WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC. XPER IM PHYSIOMONITORING 5 HOST; PHYSIO-MONITORING SYSTEM

Model Number 4522 300 34961

Device Problems Computer Software Problem (1112); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Ref u/f number (b)(4).

Manufacturer Narrative

A database search was performed, reviewed by a clinical healthcare professional and engineers at philips.The database search confirmed that on (b)(6) 2014, rn called the philips customer service personnel with the issue of "when they used sequence for their pullback, it would not mark the pullback and the record continued to stay on." this was recorded under complaint (b)(4).Software customer services (scs) support personnel instructed the account to perform a reboot of the system, at which point the account was able to see the values of the pullback in the list.Then scs remotely connected to the account's station ip 10.19.214.80 and confirmed that the firewall was off, the system permissions were correct and the antivirus was not running.These are the correct system configurations as expected for the unit to function correctly.An adjustment to the sql memory setting was done at that time, but is not considered relevant to this issue.Customer service personnel reviewed the full disclosure and logs related to this case.Both the logs and full disclosure were reviewed and did not show any errors.As a preventive measure, philips support personnel have filed a software anomaly with the engineering team to review the reported issue.Currently, the issue cannot be reproduced by scs in a test environment and no additional calls were received from the account after the customer assistance was provided for this issue.Conclusion summary: evaluation of the regulatory requirements was performed.21 cfr 803.50(a) states a manufacturer must report if information reasonably suggests a device "may have caused or contributed to a death or serious injury; or has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur." for the reported issue there was not a death or serious injury reported, nor was there a potential for a death / serious injury.If monitor fails or displays incorrect data clinical professionals will manually assess the patient and utilize alternate monitoring equipment (which is specified/recommended in our labeling) before initiating treatment.In addition, a full disclosure file is available to be able to acquire any needed pullback information after the fact.

• Brand Name: XPER IM PHYSIOMONITORING 5 HOST
• Type of Device: PHYSIO-MONITORING SYSTEM
• Manufacturer (Section D): WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC.; 305 north dr.; melbourne FL 32934
• Manufacturer Contact: linda morrison ; 3000 minuteman rd.; andover, MA 01810 ; 9786592006
• MDR Report Key: 4046808
• MDR Text Key: 4815722
• Report Number: 1039368-2014-00001
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4522 300 34961
• Device Catalogue Number: FCV4709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1