MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. EFFICIA DFM100; DEFIBRILLATOR

Model Number 866199

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

It was reported to philips that it was found that some symbols on device label and packaging label were not explained in the instructions for use (ifu).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

A follow up report will be submitted upon completion of the investigation h3 other text : some symbols on dfm100 product label and packaging label were not explained in the instructions for use (ifu).

Manufacturer Narrative

This report based on potential safety and/or compliance issues related to philips distributed products.The scope of this assessment is symbols on the dfm100 product label [ref-02] and dfm100 packaging label [ref-03] not defined in the dfm100 ifu symbols glossary.Complaint and distribution data from other philips products were not included in this assessment.The labeling non-conformance related to safety, efficacy, quality, or regulatory requirements.During the internal review in als product label localization project [ref-10], it was found that some symbols on the dfm100 product label [ref-02] and packaging label [ref-03] were not defined in the dfm100 ifu symbols glossary [ref-04].The symbols that convey directions for use are not defined in dfm100 ifu [ref-04] symbol glossary.Therefore, the device may be used in a way or in an environment that the device is not indicated for.This may cause the device to fail in clinical use and lead to a delay in or no therapy.There is also a regulatory non-compliance for this issue because this fails iso 20417 [ref-05] sub-clause 6.1.3 f) requirement: ¿if the label includes symbols or safety-related colors, they shall be explained in the instructions for use.¿ although, the dfm100 ifu [ref-04] conveys these directions for use elsewhere in the ifu without the use of the symbols.See appendix 1 for excerpts.Since the symbols that convey instructions for use are not defined, the device may be used in a way or in an environment that the device is not indicated for.This may cause the device to fail in clinical use and lead to a delay in or no therapy.There were no complaints, the worst-case severity was chosen based on the hazard.Saf-37, env-06, env-01, and mon-30 all have a maximum severity of s3.Therefore, s3 will be selected as the severity level for all possible complaints.Dfm100 ifu [ref-09] is proto-release status for revision min edmr, the missing symbol definitions are updated.

• Brand Name: EFFICIA DFM100
• 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: 18146233
• MDR Text Key: 328233749
• Report Number: 3030677-2023-04501
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• 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 Model Number: 866199
• Device Catalogue Number: 866199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: No
• 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