MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CODEMASTER XL+; DEFIB/MONITOR

Model Number M1722A

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that the device is not turning on.There was no reported patient involvement/adverse patient impact.

Manufacturer Narrative

Since the device is no longer supported, no resolution is warranted.The device remains at the customer site.

• Brand Name: CODEMASTER XL+
• Type of Device: DEFIB/MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7309488
• MDR Text Key: 101499807
• Report Number: 1218950-2018-02230
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1722A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/1995
• 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