MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC TELE PWM,802.11A/B/G,ECG ONLY,EX,NON US

Model Number 453564615351

Device Problems Defective Alarm (1014); Defective Component (2292)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

The customer reported that they want to request an exchange for an mx40 as the speaker is defective.It is unknown if the device as in use or patient involvement at the time of the event.

Event Description

The customer contacted philips about a loudspeaker being defective on a mx40.The customer was requesting an exchange with no bench repair.The customer was sent an exchange mx40 which arrived onsite as intended.No patients were harmed or any allegation of injury or death.

• Brand Name: TELE PWM,802.11A/B/G,ECG ONLY,EX,NON US
• Type of Device: TELE PWM,802.11A/B/G,ECG ONLY,EX,NON US
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15573123
• MDR Text Key: 302419528
• Report Number: 1218950-2022-00895
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K103646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: Other
• Device Model Number: 453564615351
• Device Catalogue Number: 453564615351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/25/2022
• 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