MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Unspecified Heart Problem (4454); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported to philips the user was not able to shock.At around 23:30 on (b)(6) 2021, a first shock was delivered using a defibrillation pad, but the analysis was completed at the time of the second use.The second shock could not be delivered even when the discharge button was pressed.The defibrillation pad was replaced with an external paddle and the discharge button was pressed, but the shock could not be delivered.Another device was used to treat the patient.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.

Event Description

It was reported to philips the user was not able to shock.At around 23:30 on (b)(6) 2021, a first shock was delivered using a defibrillation pad, but the analysis was completed at the time of the second use.The second shock could not be delivered even when the discharge button was pressed.The defibrillation pad was replaced with an external paddle and the discharge button was pressed, but the shock could not be delivered.Another device was used to treat the patient.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The heartstart xl was evaluated by a philips field service engineer (fse) and it was determined it will not be repairable.A philips clinician is currently reviewing the pictures of event strips forwarded by the fse; a final report will be sent upon receipt of the review.According to service bulletin (b)(4), the m4735a heart/start xl portable defibrillator/monitor was discontinued on 31-december -2013.All options associated with this defibrillator were discontinued as of 31-december-2013.The end of support date for the device is 31-december -2018.The customer was aware of the end of life terms and the device remains at the customer site.

Event Description

It was reported to philips the user was not able to shock.At around 23:30 on (b)(6) 2021, a first shock was delivered using a defibrillation pad, but the analysis was completed at the time of the second use.The second shock could not be delivered even when the discharge button was pressed.The defibrillation pad was replaced with an external paddle and the discharge button was pressed, but the shock could not be delivered.Another device was used to treat the patient.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The heartstart xl was evaluated by a philips field service engineer (fse) and it was determined it will not be repairable.A philips clinician is currently reviewing the pictures of event strips forwarded by the fse.A philips clinician reviewed eighteen jpeg images which were photos of ecg rhythm strips and possibly other waveforms.Due to the quality of the image resolution, none of the alpha numeric characters could be read.Because of this, it was not possible to determine the date, time, ecg lead or any other information typically found on an ecg rhythm strip.It was not possible to place any of the images into chronological order to determine context for this device use.The resolution was sufficiently adequate on some of the jpeg images to determine that the ecg rhythm was an organized narrow complex that would not be considered shockable.Other ecg rhythm segments were not clear enough to identify the rhythm.It is not possible to provide a clinical review of the device behavior based on the information available.According to service bulletin sb86100166d, the m4735a heart/start xl portable defibrillator/monitor was discontinued on 31-december -2013.All options associated with this defibrillator were discontinued as of 31-december-2013.The end of support date for the device is 31-december -2018.The customer was aware of the end of life terms and the device remains at the customer site.

• Brand Name: HEART START XL
• Type of Device: 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: jacqueline nishino ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12713076
• MDR Text Key: 278832504
• Report Number: 3030677-2021-15274
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• 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

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Device Catalogue Number: M4735A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening; Required Intervention