MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS INTELLIVUE; DETECTOR AND ALARM, ARRHYTHMIA

Model Number M4841A

Device Problems Material Erosion (1214); Overheating of Device (1437); Battery Problem (2885); Moisture or Humidity Problem (2986)

Patient Problem Insufficient Information (4580)

Event Date 05/29/2018

Event Type  malfunction  

Event Description

Due to design issues with the philips intellivue telemetry box, including fluid intrusion, the box overheated during patient use.Caregivers then discovered erosion in the battery cage and battery acid leaking out of the unit.

• Brand Name: PHILIPS INTELLIVUE
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 12672340
• MDR Text Key: 277691406
• Report Number: 12672340
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4841A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2021
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA