MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem No Audible Alarm (1019)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 04/28/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.(b)(6).

Event Description

The customer has reported that their monitor failed to alarm for asystole for approximately 90 seconds.The customer has reported that the monitor was alarming normally for episodes of bradycardia before the asystole episode began.A staff member noticed that the patient had been in asystole and a code was called.The patient was transferred to a transport monitor while using the same ecg lead set with no issues.The patient survived the incident, and the faulty monitor was replaced with a working monitor.

Manufacturer Narrative

The customer¿s biomedical engineer has been unable to replicate the fault, and a philips employee has not performed a device evaluation.A vtach alarm sounded on (b)(6) 2019 at 06:41 and an abp disconnect alarm sounded on (b)(6) 2019 at 06:52 am.After 06:43, a hr of 23, an spo2 of 89, and a abp of 52 were recorded.These conditions should have triggered separate alarms independent of ecg alarms, but were not captured in the monitor's alarm review that has been provided to philips.The monitor's configuration file states that ecg alarms were set to be able to be turned off and that the pause alarm setting had a duration of three minutes.No indication of the actual alarm on/off state during the time of the event has been provided to philips; insufficient information is available to determine if the monitor failed to alarm.A loaner monitor was provided to the customer after the patient event.A philips response center engineer (rce) provided the customer with troubleshooting options, including a software reload, main board replacement and/or bench repair.The customer has declined these options and has permanently removed the device from service.No subsequent calls have been logged for this device/issue.No further investigation is warranted at this time.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: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8650331
• MDR Text Key: 146413806
• Report Number: 9610816-2019-00138
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• 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: 04/30/2019

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: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention