MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0; CLINICAL INFORMATION MANAGEMENT SYSTEM

Model Number	866148
Health Effect - Clinical Code	Overdose (1988)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.Patient information has been requested.Serial number is unknown at time of report.
Event or Problem Description
The customer has alleged a drug "overdose" event occurred due to a user drug order configuration that resulted in a overdose of paracetamol iv where a 3.5 kg patient was prescribed 45 mg of paracetamol iv and the max should be 10 mg/kg iv for this patient.The drug was given.While it was described that the patient was not harmed, based on the patient being an infant and the inappropriate dosing, conservatively philips will classify this event as a serious injury based upon the limited initial information provided.
Additional Manufacturer Narrative
The customer technical support.The philips clinical staff was then contacted and investigated the problem and determined this to be a workflow error concerning "patient type" configuration.The customer was then advised on how the pharmacist can modify the drug configuration by using" patient type" that will distinguish drug dose limits for adult or pediatric patients.The configured dose was incorrect since "patient type" was not modified for pediatric where upper and lower dosage bounds would be properly configured.The customer was advised on patient type configuration and confirmed this was a use error.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: INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
• Common Device Name: CLINICAL INFORMATION MANAGEMENT SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 7837275
• Report Number: 1218950-2018-07055
• Device Sequence Number: 2348082
• Product Code: DXJ
• UDI-Device Identifier: 00884838033672
• UDI-Public: (01)00884838033672
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 866148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other