MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 (W B) HOME DEFIB, US ENGLISH, EXCHG; AED

Model Number M5068A

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

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

• Brand Name: HS1 (W B) HOME DEFIB, US ENGLISH, 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: shannon decker ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 11396143
• MDR Text Key: 234225070
• Report Number: 3030677-2021-10040
• Device Sequence Number: 1
• Product Code: NSA
• UDI-Device Identifier: 00884838075849
• UDI-Public: 00884838075849
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M5068A
• Device Catalogue Number: 453564596101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1