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

Model Number M5066A

Device Problem Premature Discharge of Battery (1057)

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

Event Type  malfunction  

Event Description

It has been reported that the device may be draining batteries prematurely.

Event Description

It was reported that batteries were not lasting as long as they were expected to, when installed in this device and left in standby.

Manufacturer Narrative

Based on the available details, the evaluation determined that an investigation was required.The device was requested for investigation by philips ecr failure analysis.The customer was provided with a replacement aed.Insufficient information is available to support final failure analysis.Documented number of unsuccessful attempts was made to retrieve the device per the complaint record detail.Was the device being used on a patient at the time of the event, including for the purposes of diagnosis? no.Was there any adverse event to the patient or user? if yes, describe? no.If there was an adverse event, did the device cause or contribute to the adverse event, and how? no.

• Brand Name: HS1 (W B) DEFIB, ITALIAN, 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: 15217927
• MDR Text Key: 302837846
• Report Number: 3030677-2022-03929
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838075849
• UDI-Public: 00884838075849
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• 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: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5066A
• Device Catalogue Number: 453564592861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1