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

Model Number M5066A

Device Problems No Audible Prompt/Feedback (2282); 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.

Event Description

It has been reported that the device is failing self-test and the speakers were not functioning properly.

• 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: 12024191
• MDR Text Key: 257168231
• Report Number: 3030677-2021-11982
• 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,Followup,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Distributor Facility Aware Date: 05/26/2021
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 06/16/2021; 07/20/2021; 09/15/2021
• Supplement Dates FDA Received: 07/15/2021; 07/21/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1