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

Model Number M5066A

Device Problem No Audible Prompt/Feedback (2282)

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

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Previously reported on (b)(4) with mdr# 3030677-2021-12003.Investigation will take place on(b)(4) with mdr# 3030677-2021-12003.Investigation is pending the return of the device.

• 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
• MDR Report Key: 11938843
• MDR Text Key: 254264343
• Report Number: 3030677-2021-12003
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838075849
• UDI-Public: 00884838075849
• Combination Product (y/n): N
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Distributor Facility Aware Date: 05/26/2021
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1