MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MULTI MEASUREMENT SERVER X2; PATIENT MONITOR

Model Number M3002A

Device Problems Disconnection (1171); Wireless Communication Problem (3283)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported a patient to have had a leads off blue inop for about 12 minutes.Customer is questioning if the leads were actually off or if the device was just not picking up the patient wirelessly.The patient was unresponsive and found to be in vt.Code called but the patient passed away.

Manufacturer Narrative

H10: strips were analyzed by a product support engineer and they were able to confirm that communication to the piic was maintained as no inop stating "no data from bed" was recorded.The ¿ecg leads off¿ inop shown in the 10 page strip report indicates the network connection was established.The strip report which was provided begins at 19:06:01.There is no ecg at this point when the strip provided begins and the inop for ecg leads off is present.An ecg was reestablished again at 19:07:41.The device did not fail to work as intended.This issue was not caused by a malfunction of the device.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: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11372836
• MDR Text Key: 233293528
• Report Number: 9610816-2021-00057
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K071426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3002A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death