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

Model Number 866148

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Death (1802)

Event Date 10/23/2015

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported a nurse did not follow protocol and administered incorrect blood type to 1 of 2 patients who had identical names resulting in a patient death.

Manufacturer Narrative

A clinician did not follow protocol and administered incorrect blood type to 1 of two patients who had identical names resulting in a patient death.The customer has alleged a potential safety issue but did not indicate that they thought a malfunction occurred.The customer states the system should alert and distinguish patients with identical names.The customer is claiming that the design is suboptimal and puts patients at risk.Icca does provide a bed affinity feature that helps mitigate this type of error.For fixed location workstations (at the end of the bed) the customer can configure that workstation to automatically select the patient in a particular bed when logging on to the system (icca revision g).Philips representatives visited the site and provided suggestions on preventative measures that can be taken to avoid mistaken patient identities.This was a clinical error in workflow.The icca system was operating to specifications.

• 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: wendy chadbourne ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5188768
• MDR Text Key: 30276021
• Report Number: 1218950-2015-05786
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 866148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other