MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FRX (W B) DEFIB, POLISH, EXCHG; AED

Model Number 861304

Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)

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

Event Type  malfunction  

Event Description

It has been reported that device speakers are not functioning properly.

Manufacturer Narrative

Device has not been returned for investigation.Confirmation of user allegation of a potential device issue has been observed.

• Brand Name: FRX (W B) DEFIB, POLISH, EXCHG
• Type of Device: AED
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 18908727
• MDR Text Key: 337740329
• Report Number: 3030677-2024-00968
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838080768
• UDI-Public: 00884838080768
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P180028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 861304
• Device Catalogue Number: 453564595741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1