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

Model Number	866334
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that compurecord data was incorrect.Recent findings that a software defect is the root cause of the incorrect compurecord data.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
Additional Manufacturer Narrative
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
• Common Device Name: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10643833
• Report Number: 1218950-2020-05927
• Device Sequence Number: 19606532
• Product Code: BSZ
• UDI-Device Identifier: 00884838044487
• UDI-Public: (01)00884838044487
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K083413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866334
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/11/2020
• 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