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

Model Number 866199

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/21/2022

Event Type  Death  

Event Description

During intensive care, the defibrillator was placed on the bed and the screen turned off several times, to turn it back on, customer had to touch the battery.There was a reported patient death.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

Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone: n/a.Reporter phone: (b)(6).A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The site biomed evaluated the device and performed the functional tests on the device which passed.The remote service engineer (rse) reviewed the software error log and confirmed device battery was disarmed when the device was being used on the bed as the battery may have moved out of its location and caused the power failure.The biomed could reproduce this by taking out the battery when the device was on.A philips remote service engineer (rse) reviewed the logs and found there was an error message during the night of the event.The rse confirmed the hardware error was the root cause of the battery connection lost which caused the device to power off.The customer confirmed that the death was not related to a malfunction of the device but was due to user error.It is unknown what actually caused a loose battery connection.The device remains at the site.No further action at this time.

Event Description

During intensive care, the dfm100 was placed on the bed.As soon as it was mobilized, the screen of the latter turned off, not allowing monitoring the trace.Seen within the department, the device turned back on when they touched the back of the device at the battery level.The device was being used for monitoring functions.The patient died later during the night, but the device was not involved.

• Brand Name: EFFICIA DFM100
• Type of Device: XL+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: 15516303
• MDR Text Key: 300898331
• Report Number: 3030677-2022-04503
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866199
• Device Catalogue Number: 866199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2022
• 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
• Patient Outcome(s): Death