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

Model Number M4841A

Device Problem Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The hospital's clinical manager reported that on (b)(6) 2020 a patient was being monitored with the patient worn device.The device lost ecg signal and showed a "leads unavailable" alarm message at the piic ix.The patient was found unresponsive and resuscitation attempts which began at 19:14 on (b)(6) 2020 were unsuccessful.The patient expired on (b)(6) 2020.

Manufacturer Narrative

Corrected from malfunction to death.

Manufacturer Narrative

A philips field service engineer (fse) retrieved the philips intellivue information center (piic) audit log, piic rfda log, and piic device debug log, from the site.The time of death was requested, but was not provided and the exact timeframe of the event was not provided.Neither the m4841a telemetry transmitter nor its battery adapter tray were made available for evaluation, only pictures of the battery adapter tray, battery connection, and leads were obtained.Our philips product support engineer (pse) and clinical product specialist (cps) reviewed the manufacturing history of the m4841a, logs from the m4841a and the piic, and pictures of the m4841a battery adapter tray, battery connection, and leads.The philips clinical product specialist (cps) provided an assessment of the audit logs.The last ecg leads off and leadset unplugged technical alarm started at 11:46:48 am on the day of death and ended at 16:34:50 and 16:36:23.There are no alarms from that point forward.No additional conditions were audited that would cause no ecg alarms, such as cannot analyze ecg in the b.02 release.The last actual patient alarm was a *** desat alarm at 03:24 on the day of death.At 18:48, there appears to have been re-association due to all the settings showing as entries which is normally seen with a discharge or battery change, but that is not indicated.According to the cps, there may have been a device reboot, but that is normally seen with equipment offline.According to the philips clinical support specialist (css) who interviewed the customer, the customer stated that resuscitation efforts began at 19:14.The cps¿ review of the logs determined that the ecg leads and the leadset were operational at the time of death.Concerning the ecg leads off and leadset unplugged alarms during the time that this patient was being monitored.The pse reviewed the pictures of the m4841a¿s battery adapter tray, battery connection, and leads provided by the hospital.The pse did not observe any visible damage to the connector pins or ground tabs that would impact connectivity to the ecg lead set.However, the pictures of the battery contacts showed wear.The coil springs were slightly compressed from use, with the outboard position spring having slightly more ¿set¿ than the inboard position spring.The wear/compression of the springs is not significant enough to negatively impact device functionality.The contact separator is in place between the contacts, and the molded in plastic separator is intact between the coiled contact springs at the negative side of the battery compartment.Since there were no reboot events other than those associated with the battery replacement, it is determined that the condition of the tray did not contribute to any issues with device operation.Based on our investigation, the mx40 were working as designed.The device remains at the customer site 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: 10195689
• MDR Text Key: 196781546
• Report Number: 1218950-2020-03675
• 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,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR