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

Model Number 865351

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that on (b)(6) 2020 at 14:43, the mx40 did not alarm to indicate that the device was turned off.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

Manufacturer Narrative

H10: the audit log was reviewed by the product support engineer (pse).The pse found the audit log shows that around the incident timeframe, physiological alarms were being provided for changes in the patient¿s condition.The audit log also shows inop alarms for tele battery low at 09:38:28 and tele batt empty at 09:58:58 on (b)(6) 2020.The inop was generated again at 10:09:10 on (b)(6) 2020.The rfda log shows the loss of communication between the mx40 and the pic at 10:09 on (b)(6) 2020.Connection was re-established at 10:45 on (b)(6) 2020 (battery replaced).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 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
• MDR Report Key: 11088431
• MDR Text Key: 225107609
• Report Number: 1218950-2020-08132
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other