MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problems No Device Output (1435); Communication or Transmission Problem (2896)

Patient Problem Death (1802)

Event Date 10/15/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported to philips that no capnography (etco2) reading was given by the device, showing question marks for the value and the etco2 waveform showed dashed lines. The involved patient was in cardiac arrest. Cpr was initiated by the crew. The customer did not allege that device behavior impacted patient outcome, as they reported that at no time during treatment did a pulse return to the patient.

Manufacturer Narrative

An electronic event file from 10/15/2016 at 6:06:43 pm was reviewed and indicates co2 check exhaust inop messages. An etco2 reading was not acquired. The device and accessories were evaluated by a philips field service engineer and the reported symptom was confirmed. The issue was isolated to the malfunction of the etco2 module. The etco2 module was replaced to resolve the issue. The device then passed all required performance verification testing and was placed back into use.

Event Description

It was reported to philips that no capnography (etco2) reading was given by the device, showing question marks for the value and the etco2 waveform showed dashed lines. The involved patient was in cardiac arrest. Cpr was initiated by the crew and was continuous throughout the event. Six shocks were delivered to the patient. The customer did not allege that device behavior impacted patient outcome, as they reported that at no time during treatment did a pulse return to the patient.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6093922
• MDR Text Key: 59625706
• Report Number: 1218950-2016-07105
• Device Sequence Number: 1
• Product Code: MKJ
• 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: health professional,user faci
• Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse