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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR
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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Irregular Pulse (2469)
Event Date 10/28/2020
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the customer performed non-invasive pacing with demand mode for a patient who had low hr (39-40 bpm) and the patient pulse did not increase after pacing.The device was reported to be in use on a patient, causing a delay in possible life threatening therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.Additional details have been requested.
 
Event Description
It was reported to philips that the customer performed non-invasive pacing with demand mode for a patient who had low hr (39-40 bpm) and the patient pulse did not increase after pacing.The device was reported to be in use on a patient, causing a delay in possible life saving therapy/treatment and will be considered a serious injury.However, there was no impact to the patient.The customer the philips response center.The customer provided three pictures of strips from the printed event summary.A philips clinician reviewed the event strips.No associated ecg waveforms were provided for review.No information beyond the time of 09:21:46 was available for review.The heartstart mrx allows users to select ma values between 10-175 ma.The highest ma selection was 80 ma.The available information suggests that the patient may have required a higher ma selection than 80 to achieve pacing capture to bring the patient¿s heart rate to the selected rate.However, there is no information about the event after 09:21:46 and there are no ecg strips for the entire event.Therefore, philips is unable to confirm the cause of the reported symptom.The philips authorized channel partner sales engineer visited the customer site and investigated the device.The device tested normal.The device remains with the customer.
 
Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
HEARTSTART MRX
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key11037105
MDR Text Key222324023
Report Number1218950-2020-07940
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public(01)00884838000018
Combination Product (y/n)N
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 12/10/2020
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 NumberM3535A
Device Catalogue NumberM3535A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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