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

Model Number 866148

Device Problems Failure to Transmit Record (1521); Wireless Communication Problem (3283)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Unable to confirm serial number.Phone provided insufficient: (b)(6).

Event Description

The customer alleged "medication administration report (mar) cannot pass urgent printout to pharmacy.The device was not in use on a patient.

• Brand Name: INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
• Type of Device: CLINICAL INFORMATION MANAGEMENT SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9533708
• MDR Text Key: 177836856
• Report Number: 1218950-2019-09898
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 866148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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