MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problems Device Alarm System (1012); Pacing Problem (1439)

Patient Problem Death (1802)

Event Date 07/11/2015

Event Type  Death  

Event Description

The customer reported that the pacer detection was not turned on for a paced patient and the mx40 telemetry device failed to alarm for an asystole event resulting in a patient death.

Manufacturer Narrative

A field service engineer (fse) went to the customer site on (b)(6) 2015 and was told by the customer's biomedical engineer that they did not want philips to evaluate the device involved in the reported incident.The biomed stated that they were going to do an internal investigation and did not require philips testing of the device.Since the customer would not allow philips to evaluate the device we cannot confirm that the device was operating per specifications.The device remains at the customer site.A patient death occurred.The customer reported that the pacer detection was not turned on for a paced patient and the mx40 telemetry device failed to alarm for an asystole event resulting in a patient death.Strips were provided for (b)(4) on (b)(6) 2015 from 18:44 to 18:50 timeframe.The strips demonstrate that paced mode was set for: not paced at 18:44 on (b)(6) 2015 a paced rhythm is shown with "n" for normal beat labels instead of "p" for paced which is what would be expected for a paced rhythm when pacing is turned on.Strip shows occasional failure to capture with pace pulse shown but no captured beat.At 18:47 there are increasing failed capture with absent qrss.Pacer spikes are being labeled as "a" or "v" as the system attempts to classify these as beats.At 18:50 the hr is listed as 68 which is reflecting only spikes.There are only 3 captured beats on the page in approximately a 20 second timeframe.The strips are consistent with behavior when pacing is not turned on.Product labeling provides explicit warnings about the importance of enabling paced mode for paced patients to avoid such occurrences.The information is not consistent with any product malfunction.The issue is consistent with a use issue.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.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 4921570
• MDR Text Key: 16531132
• Report Number: 1218950-2015-03780
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/13/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2014
• 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