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

Model Number 866334

Device Problem Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Customer did not provide serial number.Phone not provided.A follow-up report will be submitted once the investigation is complete.The product grid is pending additional information.A follow-up report will be submitted.

Event Description

Customer reported that compurecord data was incorrect.The device was in use on a patient.There was no report of patient or user harm.

• 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
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 10645085
• MDR Text Key: 211437000
• Report Number: 1218950-2020-05839
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00884838044487
• UDI-Public: (01)00884838044487
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 866334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 11/10/2020
• 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): Other