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

Model Number 865230

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

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

• 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: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 10621141
• MDR Text Key: 210405880
• Report Number: 1218950-2020-05807
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00884838022942
• UDI-Public: (01)00884838022942
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• 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: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2010
• 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