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

Model Number M1722A

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to philips that the joule readings on the device were off, when the customer selected 300j it read 330j.There was no reported patient or user involvement and no adverse patient/user impact.

• Brand Name: CODEMASTER XL+
• Type of Device: DEFIB/MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: danielle breitweiser ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8807947
• MDR Text Key: 151707903
• Report Number: 1218950-2019-05295
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/01/2019

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: M1722A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/1993
• 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