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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 12/05/2014

Event Type  Death  

Event Description

The customer stated that the patient was intubated, and sitting on the couch, then extubated herself, and took ecg leads off.The staff stated that they did not hear the alarms for ecg.The involved patient died.

Manufacturer Narrative

(b)(4).The alarm logs show that the device did alarm for ecg, and desat multiple times.The alarms were not silenced at the central or suspended but may have been silenced at the bedside as repeated new alarms for the same condition are noted.A philips field service engineer evaluated the device and could not reproduce the reported symptom.The device passed all testing and is fully operational.(b)(6).The logs show that the device did provide several alarms for desat and tachycardia.The device remains at the customer site.The evaluation of the device logs showed that multiple alarms occurred for both ecg and desaturation during 14:43 to 19:45 on (b)(6) 2014.There is no information supporting a malfunction of the device.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; böeblingen 7103 4; GM 71034
• Manufacturer Contact: richa shah ; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• MDR Report Key: 4953768
• MDR Text Key: 6033873
• Report Number: 9610816-2015-00143
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2014

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: Health Professional
• Device Model Number: M8007A
• Device Lot Number: XXXXXXX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Death