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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR Back to Search Results
Model Number M8007A
Device Problem No Audible Alarm (1019)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that they had an asystole rhythm, but the monitor had no audible or visible alarm. The device was in clinical use for patient care. No patient information was provided.
 
Manufacturer Narrative
A philips field service engineer (fse) went onsite and checked the device; no fault or device malfunction was found. The fse checked the iic logs, and could not find a fault. Product operation and performance was tested; the device operated normally. Further review of the logs by philips determined that ecg related arrhythmia alarms until arrhythmia alarms were turned off on (b)(6) at 19:53. In spite of the arrhythmia alarms being turned off, asystole alarms would be expected if the patient condition met the configurable criteria for this alarm, per the ifu for this device. It is not known how long the alleged asystole lasted, but no adverse impact or immediate clinical care was reported. The configuration for asystole includes extended asystole detection, where additional time is allowed before alarming and the asystole alarm threshold can be configured. If a patient is paced, failure to select that will prevent the monitor from detecting that the patient is in asystole. Given that no patient data was provided or even description of the alleged asystole, the available data does not support that there was a patient condition that met the configured criteria for asystole alarming for this device. The device remains at the customer site. No subsequent calls were logged by this customer for this type of device. The philips field service engineer (fse) tested the product operation and performance; the device operated normally. A review of the device logs determined that the arrhythmia alarms had been turned off several days prior to the reported event; the arrhythmia alarms were turned on, after the reported event. With arrhythmia alarms turned off, asystole alarms are still active. We cannot determine if there was a patient condition that met the configured criteria for asystole, so philips cannot verify nor rule out malfunction. The device remains at the customer site. No subsequent calls were logged by this customer for this type of device. No further investigation is warranted at this time.
 
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Brand NameMP70 INTELLIVUE PATIENT MONITOR
Type of DevicePATIENT 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
betty harris
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key5538422
MDR Text Key41568524
Report Number9610816-2016-00079
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K021300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM8007A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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