MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS COMPURECORD REL. F.0

Model Number 865230

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

Patient Problem Cardiac Arrest (1762)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Users claim that n2o orders displayed in computer record charting should not have been present.A patient received the n2o which has been alleged to have resulted in the cardiac arrest and cpr was imperative.N2o was contraindicated for this patient due to past medical history.The patient suffered cardiac arrest.

Manufacturer Narrative

The customer stated that the recorded n2o values administered to the patient may have contributed to a patient s cardiac arrest.The compurecord anesthesia recorder and is not a monitoring or a gas distribution device.Anesthesia record documentation is retrospective and occurs after care has been delivered.The customer was contacted by a philips senior compurecord product engineer the customer was informed there is no mechanism by which ezrecord can send commands to a gas machine to tell the machine to administer a particular gas and its sole purpose is a recording device.The customer was informed on compurecord function.No feedback was requested by the customer nor is it warranted since the customer was informed of compurecord and its function.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: COMPURECORD REL. F.0
• Type of Device: COMPURECORD REL. F.0
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7758118
• MDR Text Key: 116284925
• Report Number: 1218950-2018-06123
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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): Other