MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1+ (W G) DEFIB, JAPANESE, EXCHG; AED

Model Number M5066A

Device Problems No Audible Alarm (1019); No Audible Prompt/Feedback (2282); Output Problem (3005)

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

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Updated the device problem code.Updated the component code.

Manufacturer Narrative

Updated the device problem code.

• Brand Name: HS1+ (W G) DEFIB, JAPANESE, 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: 17191423
• MDR Text Key: 317749256
• Report Number: 3030677-2023-02484
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838075849
• UDI-Public: 00884838075849
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5066A
• Device Catalogue Number: 453564508241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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