MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 HOME DEFIB, US ENGLISH, EXCHANGE; AED

Model Number M5068A

Device Problem Failure of Device to Self-Test (2937)

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

Event Type  malfunction  

Event Description

It has been reported that the device is failing self-test.

• Brand Name: HS1 HOME DEFIB, US ENGLISH, EXCHANGE
• 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: marie-therese assaf ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16552370
• MDR Text Key: 311388873
• Report Number: 3030677-2023-01126
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5068A
• Device Catalogue Number: M5068-RFABA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1