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

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problem Loss of consciousness (2418)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Serial number not provided.Medwatch number (b)(4).

Event Description

The customer reported that a patient felt that he passed out.The patient was showing ventricular standstill on the monitor but the telemetry failed to provide a red alarm.The patient was transferred to a higher level of care for ventricular standstill.The patient was discharged on (b)(6) 2017.The information indicates that urgent medical interventions may have been required.If alarms are delayed, harm is possible.The patient was showing ventricular standstill on the monitor but the telemetry failed to provide a red alarm.The patient was transferred to a higher level of care for ventricular standstill.

Manufacturer Narrative

Based on the limited available information we cannot determine the cause or resolution of the reported issue.The customer filed a medwatch, with no direct to call to philips.Several attempts were made to the customer for additional information, with no additional responses.Philips received some additional information from the customer regarding the patient information.Device testing answers were written as "unknown".Philips will consider that the device may have been a factor in the incident with the patient based on the fact that insufficient details were provided to confirm the device was not a factor.

• 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: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6986353
• MDR Text Key: 90506391
• Report Number: 1218950-2017-07426
• 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 faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

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: 865350
• Device Lot Number: CUSTOMER DID NOT PROVIDE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR
• Patient Weight: 71