MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS V24/26 COMPONENT MONITORING SYSTEM; BEDSIDE MONITOR

Model Number M1205A

Device Problem Wireless Communication Problem (3283)

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

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review.

Event Description

The customer reported that they had delays getting messages on their paging system.The device was in use at the time of the event.There was no reported patient impact.

• Brand Name: V24/26 COMPONENT MONITORING SYSTEM
• Type of Device: BEDSIDE MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: kimberly shelly ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 11715232
• MDR Text Key: 249428471
• Report Number: 1218950-2020-06209
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2018

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: No Information
• Device Model Number: M1205A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2002
• 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