MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART; DEFIBRILLATOR

Model Number	M3713A
Medical Device Problem Codes	Degraded (1153); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported to philips that the m3713a pad gel is unusually sticky and tight, which prevents the clinical staff from using it properly, and the hydrogel is avulsed.It was also reported that after use, the hydrogel sticks to the patient's body and is difficult to clean.There was no reported patient impact or injury.
Event or Problem Description
Philips received a complaint on the philips m3713a multifunction adult/child electrode pads plus indicating that a set of pads was unusually sticky, and it was difficult to clean the gel off of the patient after use.There was reportedly no patient harm.
Additional Manufacturer Narrative
This report is based on information provided by the local philips customer support team and has been investigated by the philips complaint handling team.Philips received a complaint on the philips m3713a multifunction adult/child electrode pads plus indicating that a set of pads was unusually sticky, and it was difficult to clean the gel off of the patient after use.There was reportedly no patient harm.A good faith effort was made to obtain additional information associated with this complaint evaluation, but there is no additional information available.Photographs provided with the customer feedback illustrate melted gel.Based on the available details, the evaluation determined that an investigation was required.The pads were requested for investigation by philips ecr failure analysis.The customer was provided with replacement pads.Based on the information available, the cause of the reported problem was melted gel.The pads were not returned for additional investigation.The reported problem was confirmed.The customer was provided with replacement pads.Further action has been initiated.If additional information is received the complaint file will be reopened.Scar 3967213 initiated to address this known issue.H3 other text : device not returned.
Additional Manufacturer Narrative
This report is based on information provided by the local philips customer support team and has been investigated by the philips complaint handling team.Philips received a complaint on the philips m3713a multifunction adult/child electrode pads plus indicating that a set of pads was unusually sticky and it was difficult to clean the gel off of the patient after use.There was reportedly no patient harm.A good faith effort was made to obtain additional information associated with this complaint evaluation, but there is no additional information available.Photographs provided with the customer feedback illustrate melted gel.Based on the available details, the evaluation determined that an investigation was required.The pads were requested for investigation by philips ecr failure analysis.The customer was provided with replacement pads.Based on the information available, the cause of the reported problem was melted gel.The root cause of the reported problem could not be confirmed because the pads were not returned for additional investigation.The reported problem was confirmed.The customer was provided with replacement pads.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : device not returned.

• Brand Name: HEARTSTART
• Common Device Name: DEFIBRILLATOR
• 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: 17259545
• Report Number: 3030677-2023-02659
• Device Sequence Number: 17632458
• Product Code: MKJ
• UDI-Device Identifier: 00884838002845
• UDI-Public: 00884838002845
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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
• Operator of Device: Health Professional
• Device Model Number: M3713A
• Device Catalogue Number: M3713A
• Device Lot Number: 030922-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 06/13/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 12/04/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown