MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 4.4 GHZ SMART HOPPING

Model Number 865350

Device Problems Failure to Read Input Signal (1581); Low Battery (2584); Communication or Transmission Problem (2896)

Patient Problem Death (1802)

Event Date 10/03/2014

Event Type  Death  

Event Description

The customer reported that a patient was being monitored with a philips mx40 telemetry device.Reportedly, the battery in the corresponding device was fully depleted while the patient was registering red alarms on the monitor.The batteries were replaced; however, the nursing staff soon realized that the central station was not receiving a signal from the telemetry device.The patient was found to be unresponsive when the user went to check the device.The patient expired several days later after being taken off life support.

Manufacturer Narrative

(b)(4): a follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The patient expired.No philips product malfunction occurred.This device was evaluated on site by a qualified service provider and was not returned to the manufacturer for evaluation.On october 20, 2014, the philips field service engineer, provided additional information related to the on-site analysis performed of this account's equipment.Reportedly, the batteries of the mx-40 device completely discharged at 23:53 on october 3, 2014 while the patient's equipment was registering red alarms (asystole and extreme brady) on the monitor.Therefore, the customer wanted verification that the system did produce battery inop messages.A review of the system logs and of the screenshots provided of the mx-40 logs confirmed that low battery alerts were received prior to batteries being fully depleted.A low battery alert was provided by the mx-40 device at 23:34 and then a battery empty alert occurred at 23:54.Furthermore, the customer stated that no malfunction of the mx-40 occurred, but wanted to confirm that all appropriate information related to this event was on file as monitoring was lost for about 10 minutes.Functional testing performed by the fse confirmed that the system was operating properly.No device malfunction was observed by the fse.Additionally, a site specific review of incoming calls was performed to identify any cases with a similar problem description generated by this account; no other reports were received following this event related to low battery alarm issues.No further action/investigation is warranted by philips.No parts were replaced.The system passed all functional testing; no trouble found.The system remains in use at the customer site.Submission of a report does not constitute an admission that the medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event.

• Brand Name: MX40 4.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: kelly rector ; 3000 minuteman rd.; andover, MA 01810 ; 9786592590
• MDR Report Key: 4224077
• MDR Text Key: 4996359
• Report Number: 1218950-2014-06495
• 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: 10/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• 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
• Date Manufacturer Received: 10/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2013
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 82 KG