MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 (W B) DEFIB SIMP. CHINESE EXCHG; AED

Model Number M5066A

Device Problem Premature Discharge of Battery (1057)

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

Event Date 10/24/2023

Event Type  Injury  

Event Description

It has been reported that the battery was prematurely drained during patient use.

Manufacturer Narrative

H10: changes made to patient outcome only.

Manufacturer Narrative

H10: change made to component code grid.

• Brand Name: HS1 (W B) DEFIB SIMP. CHINESE 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: 18278984
• MDR Text Key: 329869675
• Report Number: 3030677-2023-04827
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M5066A
• Device Catalogue Number: 453564592711
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening