MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. PHILIPS M2601B S01 ECG TELEMETRY TRANSMITTER; TELEMENTARY TRANSMITTER

Model Number FTPH2100

Device Problems Corroded (1131); Crack (1135); Melted (1385); Moisture Damage (1405); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned.Device evaluation identified that the unit had been heavily physically abused.The front case was cracked, there were missing parts, there was damage to the battery door, the watermark was compromised, and the case was melted.Due to the contact with fluid the battery terminals had become corroded.The case had melted due to the contact of fluid which caused the batteries in the device to short circuit and become hot.Additionally, the location of the physical damage of the device broke critical parts which intensified the short circuit issue.The battery terminal, battery door, and front case/housing were replaced.The circuit boards were inspected.The device set to factory reset and tested on a simulator.The case was checked for damage.The reported event was confirmed; however, the root cause is determined to be user handling.This type of event will continue to be monitored.Note: this mdr filing is part of a retrospective review.

Event Description

Reportedly, post repair, the plastic piece that separates the battery contacts becomes out of place, the contacts are touching and melting case.Additionally, there was note of corrosion.There was no report of patient involvement.No additional information is available.

• Brand Name: PHILIPS M2601B S01 ECG TELEMETRY TRANSMITTER
• Type of Device: TELEMENTARY TRANSMITTER
• 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
• MDR Report Key: 9396678
• MDR Text Key: 177839264
• Report Number: 3007409280-2019-00116
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040357
• 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: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FTPH2100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• 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