MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. PHILIPS M4841A S02 ECG & SPO2; TELEMETRY

Model Number FTPH3200

Device Problems Break (1069); Overheating of Device (1437); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found that the door was missing.Device evaluation is identified that the comport pins were pushed in; however, the reported overheating could not be confirmed.The comport pins were refurbished.The circuit boards were inspected.The spo2 rate was set to continuous.The connector dust cap cover single, alignment plug, and battery door white were all replaced.The unit was tested on a simulator and the performance and power on tests passed to oem specifications.The root cause of the confirmed damage to the connector pins is most likely due to the customer jamming a configuration tool cable into the comport pins which caused one to intrude the case.This type of event will continue to be monitored.It should be noted that this is being filed based on retrospective review.

Event Description

Reportedly, post repair, the pins became recessed in the tether connector port causing overheating.There was no report of patient involvement.No additional information is available.

• Brand Name: PHILIPS M4841A S02 ECG & SPO2
• Type of Device: TELEMETRY
• 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: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 9667778
• MDR Text Key: 177837568
• Report Number: 3007409280-2020-00031
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/21/2019

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: FTPH3200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1