MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. PHILIPS M4841A S01 ECG ONLY TELEMETRY TRANSMITTER (FINISHED); M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TEL

Model Number FTPH3100

Device Problems Overheating of Device (1437); Failure to Power Up (1476)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The reported issue states: doesn't power on and gets warm after the batteries are installed for a little while.It returned from repair 5/18/2021 and was put back into service (b)(6) 2021 (as found the batteries were installed correctly and warm to the touch).It is unknown if there was patient involvement.There was no report of patient harm.The complaint device was returned for evaluation.Technical evaluation identified extensive fluid intrusion and damage to all internal components.Additionally, all pcb's had slight corrosion from fluid intrusion.There was no power running through the ecg pcb nor the power pcb.The device will need to be exchanged in order to repair.The customer complaint was confirmed; however, the damages found were not related to a previous service or repair.The root cause was determined to be fluid intrusion damages resulting in the failure of internal parts and components.The device will be exchanged.No additional information is available.

Event Description

The reported issue states: doesn't power on and gets warm after the batteries are installed for a little while.It returned from repair 5/18/2021 and was put back into service (b)(6) 2021 (as found the batteries were installed correctly and warm to the touch).It is unknown if there was patient involvement.There was no report of patient harm.

• Brand Name: PHILIPS M4841A S01 ECG ONLY TELEMETRY TRANSMITTER (FINISHED)
• Type of Device: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TEL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; 3000 minuteman rd.; andover MA 01810 1099
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: robert mitchell ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 12277483
• MDR Text Key: 267027187
• Report Number: 3007409280-2021-00016
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K041741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2021

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: FTPH3100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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