MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/17/2017

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that on (b)(6) 2017 the assigned nurse walked by the patients room at 03:30 hours and the patient appeared to be resting in the bed.At approximately 03:08 the patient was found sitting at the end of the bed between the foot board and the rail.He was slumped over when the nurse entered the room.The nurse called for help and the patient was moved up in the bed.A code blue was called to the resource center (switchboard) at 03:58 hours.The nurse noted that the telemetry pack, including all leads, was attached to the patient.The battery pack door was found closed as per normal operation.It was stated that the patient expired at 04:48.The patient was being monitored by the mx40 telemetry device when they expired.

Manufacturer Narrative

No malfunction.The customer reported that the mx40 lost power and there was a patient death as a result.The piic ix and mx40 device logs were reviewed as part of the investigation of the reported adverse event that occurred on (b)(6) 2017.It was determined that rf auto shutoff was enabled, and that an ecg leads off event beginning at 03:40 on (b)(6) 2017 persisted for >10 minutes, resulting in the transmitter being turned off (no communication with the piic ix) at 03:50 am on (b)(6) 2017.A user initiated reboot (battery removed and reinserted) reestablished communication at 04:00 on (b)(6) 2017.The ecg leads off condition was not resolved, and the transmitter was turned off at 04:11 on) (b)(6) 2017.Per labeling (mx40 ifu 453564630971 page 31) for rf auto shutoff behavior, "if enabled at the information center, rf operation will shut off after the combination of 10 minutes of a leads off condition, no continuous spo2 measurement, and no short-range radio communication.A ¿transmitter off¿ inop is displayed at the information center.To resume normal operation, reconnect the lead set.Rf operation will not shut off when operating in spo2 only mode, regardless of measurement frequency, i.E.Continuously, manually, or automatically.".

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 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: 6269607
• MDR Text Key: 65491013
• Report Number: 1218950-2017-00502
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• 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
• Patient Age: 84 YR
• Patient Weight: 67