MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR

Model Number M3535A

Device Problems Failure to Deliver Energy (1211); No Pacing (3268)

Patient Problems Cardiac Arrest (1762); Heart Block (4444); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/23/2021

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 device failed to capture during pacing on patient.Additional details have been requested.The device was reported to be in use on a patient, causing a possible 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 device failed to capture during pacing on patient.The clinician changed out the pads then changed pads and placement again.Ems applied another manufacturer monitor and immediate capture was obtained.The device was reported to be in use on a patient, causing a possible 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 customer shipped the device to the philips repair bench to evaluate the device.The repair bench provided the customer with an estimate for evaluation/repair.A philips clinician reviewed the patient event file.It was found the device was powered on in monitoring mode with lead ii as the ecg source.No ecg waveform was visible from this source which would indicate that the leads were not connected to the patient.At 4:17 elapsed time, a ¿pads on¿ message was observed and the ecg lead source changed to pads automatically as designed.The ecg showed p waves (clinical asystole) followed by an erratic third degree av heart block with wide qrs complexes.At 6:11 elapsed time, the device was placed into pacer mode in the default setting of ¿demand¿.A ¿leads on¿ message was observed at 6:58 elapsed time and the ecg source switched to lead ii.The ecg was third degree heart block alternating with asystole.Pacing was started at 7:04 elapsed time at a rate of 60 paced pulses per minute (ppm) and an output of 80 ma.No electrical capture of the patient¿s heart rhythm was observed.The following changes to the pacer setting were subsequently ma;de: 00:07:42 , pacer change rate, 70 ppm; 00:07:44 , pacer change rate, 60 ppm; 00:07:47 , pacer change output, 85 ma; 00:07:48 , pacer change output, 90 ma; 00:07:52 , pacer change rate, 70 ppm; 00:09:34 , pacer change output, 95 ma; 00:09:35 , pacer change output, 90 ma; 00:10:03 , pacer change output, 95 ma; 00:10:03 , pacer change output, 100 ma; 00:11:09 , pacer change rate, 80 ppm; 00:15:11 , pacer mode change fixed 00:15:47 , pacer change output, 95 ma; 00:15:47 , pacer change output, 90 ma; 00:16:08 , pacer change output, 95 ma; 00:16:09 , pacer change output, 100 ma; numerous extreme bradycardia and asystole alarms 00:35:36 , pacer change output, 110 ma; 00:36:22 , pacer change output, 115 ma; 00:36:22 , pacer change output, 120 ma; 00:38:11 , pacer change output, 125 ma; 00:38:12 , pacer change output, 130 ma; 00:38:12 , pacer change output, 135 ma; 00:38:12 , pacer change output, 140 ma; 00:38:13 , pacer change output, 145 ma; 00:38:13 , pacer change output, 150 ma; 00:38:15 , pacer change output, 145 ma; 00:38:15 , pacer change output, 140 ma; 00:38:16 , pacer change output, 135 ma; 00:38:16 , pacer change output, 130 ma; 00:40:15 , pacer change output, 135 ma; 00:40:15 , pacer change output, 140 ma; 00:43:16 , pacer change output, 145 ma; 00:43:17 , pacer change output, 150 ma; 00:43:43 , pacer change output, 155 ma; 00:43:43 , pacer change output, 160 ma; 00:49:50 , pacer change output, 165 ma; 00:49:50 , pacer change output, 170 ma; 00:51:26 , pacer change rate, 70 ppm; 00:51:31 , pacer change output, 175 ma; 00:51:32 , pacer change output, 175 ma; (ma;ximum) 00:51:33 , pacer change output, 175 ma; 00:51:34 , pacer change output, 175 ma; 00:52:23 nbp 112/59 (77); 00:52:39 pads off; 00:52:40 , pacer stop; 00:53:06 pads on ; 00:54:06 , pacer start; 00:54:40 , pacer change output, 145 ma; 00:54:40 , pacer change output, 150 ma; 00:56:24 nbp 144/106 (119); multiple asystole and extreme bradycardia alarms.00:59:52 , pacer change output, 155 ma; 00:59:52 , pacer change output, 160 ma; 01:07:43 , pacer change output, 165 ma; 01:07:43 , pacer change output, 170 ma; 01:07:44 , pacer change output, 175 ma; 01:07:44 , pacer change output, 175 ma; 01:09:54 , pacer stop; 01:10:06 , nbp 105/54 (71); 01:10:33 , pacer start, 70 ppm; ¿ 175 ma;.Numerous asystole and extreme bradycardia alarms.01:29:06 , nbp 141/92 (108); 01:34:23 , leads off; 01:40:41 , pacer stop; 01:40:44 , pads off; 01:41:30 , device off.Despite attempts at changing the pacing rate, pacer output, and pacer mode over the course of over one hour of therapy, electrical capture was never observed.Pacer output was increased to the maximum setting available twice during the course of this event.It is not possible from the information observed in the device event file to determine how the patient could have blood pressure readings if they were not somehow being perfused as there was no observed electrical capture of the ecg by transcutaneous pacing.One possible explanation is that a second device was being used to deliver transcutaneous pacing therapy.The customer declined repair from philips.The repair bench shipped the device back to the customer unrepaired.The device remains with the customer.No conclusion can be drawn.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• 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: bethany glynn ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12174971
• MDR Text Key: 261751620
• Report Number: 3030677-2021-12979
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• 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

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: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/23/2021
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 01/11/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 95 KG