MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number 866334

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleged, ¿icca can't interface vital sign data".The device was not in use on a patient.

Manufacturer Narrative

D4: unable to confirm serial number.H10: the issue has been resolved and the device remains on site and in use.A health hazard evaluation (hhe) was performed and concludes the following: compurecord interfacing engine has a decoding defect that causes data received from approved devices to be missing or incorrect.This data is missing or incorrect to the user.The potential hazardous situations identified due to this defect include a hazard for delayed patient treatment due to missing data or incorrect data out of bounds and a hazard for incorrect patient treatment due to incorrect data.Based on conclusion of hhe the risks are acceptable and it has been determined that this event is no longer reportable.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 PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10643698
• MDR Text Key: 211432384
• Report Number: 1218950-2020-05863
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K083413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866334
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1