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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported an spo2 desaturation event occurred on (b)(6) 2020, and their mp70 intellivue patient monitor failed to alarm.There was an adverse event reported.

Manufacturer Narrative

A philips clinical application specialist (cas) visited the hospital site and met with the technical ide along with an ide from the neonatal department.Along with the members of the hospital staff, the cas highlighted the differences between the alarm limits and the parameters, including the alarm threshold at 10-seconds.The technical ide confirmed the failure of the audible alarm was due to the spo2 parameter not violating the 10-second threshold.The cas also observed the possible drifts in the alarm settings by the ide and the hospital use of the alarm pause feature.The monitor configuration for the spo2 parameter indicates a desaturation delay of 10 seconds.In the event of a desaturation and fast recovery (<10s), the monitor does not trigger an alarm on saturation.Although cannot rule out a product malfunction, the information provided by the cas and investigation findings determined a lack of training with the device by the hospital staff.The cas along with the technical ide have agreed to schedule a hospital staff training on the device use along with homogenizing the saturation alarms.The cas shared their findings with the customer who was satisfied with the information provided.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: 10476236
• MDR Text Key: 205099931
• Report Number: 9610816-2020-00305
• 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: 08/24/2020

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: 08/24/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention