MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5SC SPOTCHECK MONITOR

Model Number 865322

Device Problem Disconnection (1171)

Patient Problem Cardiac Arrest (1762)

Event Date 02/12/2021

Event Type  Injury  

Event Description

The customer called philips to report that their mp5sc bedside monitor was not "showing vital signs on the bedside monitor when pt was coding earlier today 11:34 pst" on (b)(6) 2021.A patient code has been alleged.

Manufacturer Narrative

Philips field service engineers (fse) visited the customer site and extracted the alarm audit logs and additional data.The corresponding excerpt from the piic ix alarm audit logs for h6839 is shown as consistent alarms were captured on the piicix from 10:53 until the patient was discharged at 11:53, after which no significant activity other than settings/configurations occurred.Although the short range radio disconnection between the mp5 and the mx40 occurred, philips has confirmed that no product malfunction has occurred.The customer has reported that the mp5sc showed a ¿tele disconnect¿ inop during the event and that the waveforms continued on the mx40 all while continuously transmitting data, including alarms, to the piicix.A review of the piicix alarm audit log also showed consistent alarming from 10:53 until 11:53, when the patient was discharged.The customer has confirmed operational functionality, including short range radio, of both the mp5sc and the mx40 and has continued clinical use of the devices on patients.Philips provided the customer with recommendations concerning the radio frequency codes of nearby rooms as well.The customer also resolved a site-wide network issue of quantum data loss by a software patch, which is described in further detail in (b)(4).Good faith efforts to obtain additional patient information was conducted, but the customer was not willing to provide this information.No corrective action is required at this time.The device did not cause a death or serious injury, and the available information from this complaint and its associated records does not support that this failure represents a systemic, design, or labeling problem.No further investigation is required.

• Brand Name: INTELLIVUE MP5SC SPOTCHECK MONITOR
• Type of Device: INTELLIVUE MP5SC SPOTCHECK MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 11445249
• MDR Text Key: 238633023
• Report Number: 9610816-2021-10020
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838021884
• UDI-Public: 00884838021884
• Combination Product (y/n): N
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup

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: 865322
• Device Catalogue Number: 865322
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/12/2021
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention