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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem No Code Available (3191)

Event Date 02/15/2015

Event Type  Injury  

Manufacturer Narrative

The customer stated that the device did not alarm for desat for room 353 at 22:30 on (b)(6) 2015.The logs have been evaluated and they show that the device did alarm.The device did not malfunction and did provide alarms to alert the staff of the desat event.The alarms were also acknowledged by the staff.There was no report of any adverse patient impact resulting from this reported event.The philips field service engineer (fse) went onsite to evaluate the (b)(4) monitor and spoke with the icu manager and hospital clinical educator.Audit logs obtained and sent to philips for a quality review.Observation at the bedside demonstrated both alarms heard by the fse and the biomedical engineer.The customer was instructed on the management of the alarms at the ivpm.The customer was provided with excerpts from the log files which satisfied their needs and the device is operating to specification and in use.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.

Event Description

The customer reported that the device alarm was not heard for desat for room 353 at 22:30 on (b)(6) 2015.Patient was intubated and stabilized, so this event warranted emergent clinical action to prevent serious injury.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 5317582
• MDR Text Key: 34075257
• Report Number: 9610816-2015-00312
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/19/2015

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?: No
• Device Operator: No Information
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 219