MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. EFFICIA DEFIBRILLATOR

Model Number 866199

Device Problems Computer Software Problem (1112); Poor Quality Image (1408); Failure of Device to Self-Test (2937)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported to philips that, the unit was connected to a patient with pads to monitor the patient, and the unit suddenly showed a white screen and an ¿x¿ in rfu.There was no reported patient impact or injury.Additional information has been requested.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

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 Description

This report is based on information provided by philips remote service engineer (rse) personnel and has been investigated by the philips complaint handling team.Philips received a complaint regarding the efficia dfm100, indicating that the unit showed a white screen suddenly and displayed an 'x' in rfu.The device was not in clinical use at the time the issue was discovered, and there were no reported patient impacts or injuries.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

Manufacturer Narrative

The complaint was escalated for technical investigation, and the results revealed that the medical device (dfm100) exhibited a sudden white screen and displayed an "x" in rfu, although it remains uncertain whether the rfu "x" was a solid red x or a blinking red x.Moreover, the occurrence of the rfu showing a red "x" and the unit displaying a white screen seemed to have transpired almost simultaneously.The nurse turned off the device by rotating the therapy knob from the monitoring to the off position and subsequently turned it on again by rotating the therapy knob from monitoring to the on position.With the issue subsequently being resolved during an operational check in clinical mode.Based on the available information and conducted testing, the probable cause of the reported problem the cause of the reported issue with the efficia dfm100 was identified as a potential software operation malfunction leading to the rfu red 'x' and resulting in a white screen on the lcd display due to a lack of data transfer, with no error logs indicating a hardware failure.The reported problem was confirmed.The issue was resolved during the operational check.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

This report is based on information provided by philips remote service engineer (rse) personnel and has been investigated by the philips complaint handling team.Philips received a complaint regarding the efficia dfm100, indicating that the unit showed a white screen suddenly and displayed an 'x' in rfu.The device was not in clinical use at the time the issue was discovered, and there were no reported patient impacts or injuries.The complaint was escalated for technical investigation, and the results revealed that the medical device (dfm100) exhibited a sudden white screen with an 'x' in rfu, which was subsequently resolved during an operational check in clinical mode.Based on the available information and conducted testing, the probable cause of the reported problem was identified as a software operation malfunction, potentially leading to the rfu red 'x' and resulting in a white screen on the lcd display due to a lack of data transfer, with no error logs indicating a hardware failure.The reported problem has not been confirmed.The suggested solution to address the issue was to inspect the cable connections from the ui board to the process board and from the lcd display to the ui board, especially if the problem had occurred only once, as no hardware failures were detected in the error logs.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 : remote support provided.

• Brand Name: EFFICIA DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer (Section G): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer Contact: feng she ; no.2 keji north 3rd road; nanshan district; shenzhen ; CH ; 7552698099
• MDR Report Key: 17625371
• MDR Text Key: 321977956
• Report Number: 3030677-2023-03356
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 866199
• Device Catalogue Number: 00884838057975
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 08/01/2023; 12/12/2023
• Supplement Dates FDA Received: 12/05/2023; 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2021
• 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