MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT WORN DEVICE; TELEMETRY

Model Number M4841A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Injury (2348)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital's biomed reported that on (b)(6) 2020 at approximately 4:45 am a serious injury occurred with a male patient.Details of the incident and patient outcome was requested but the biomed did not provide the information.The biomed noted there was a "no data available" inop that lasted for a period of one hour and 20 minutes.

Manufacturer Narrative

H10: on december 28, 2020, a philips field service engineer (fse) provided the philips intellivue information center (piic) audit log, piic rfda log, and piic junk.Dat log, recordmanager log, pva log, and ptmgmt log which were retrieved from the site.Neither the m4841a telemetry transmitter nor its battery adapter tray were made available for evaluation.Our philips product support engineer (pse) reviewed the logs from the m4841a and the piic and the manufacturing history of the m4841a.Our philips product support engineer (pse) provided an assessment of the audit logs for bed label 3n09b, equipment label tele 15.The rfda log shows an association between the m4841a telemetry device at 21:12 on (b)(6) 2020.From that time until 05:50 on (b)(6) 2020, there were no device disconnects (loss of association with pic).There was a loss of association between the telemetry device and the pic at 05:50 on (b)(6) 2020, with re-association occurring within 10 seconds.The junk.Dat log shows that there was a ***v-fib/tach alarm generated at 05:51 on (b)(6) 2020.The recordmanager log shows that there was a ***v-fib/tach alarm generated at 05:51 on (b)(6) 2020 and sent to the recorder.The pva log shows activity for the bed at 12:12 on (b)(6) 2020, including a change to easi lead placement.The ptmgmt log shows the device assigned to a sector at 18:47 on (b)(6) 2020.No further activity was logged until the disassociation event at 05:50 on (b)(6) 2020.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: PATIENT WORN DEVICE
• Type of Device: TELEMETRY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11089989
• MDR Text Key: 225049122
• Report Number: 1218950-2020-08137
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K040357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4841A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening