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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MUTLI MEASUREMENT SERVER (MMS); COMPACT PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS INTELLIVUE MUTLI MEASUREMENT SERVER (MMS); COMPACT PATIENT MONITOR Back to Search Results
Model Number M3001A
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 10/12/2020
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer called philips to report that, on (b)(6) 2020 around 2:30 pm cest, their multimeasurement server (mms) on bed 8 / mon 507 was reporting too low of invasive blood pressure (ibp) readings during an arterial drainage following a surgery, causing the medical staff to administer an incorrect amount of medication to the patient.
 
Manufacturer Narrative
A philips field service engineer (fse) visited the customer site around 20oct2020.The fse performed testing on the mms using a patient simulator.When the patient simulator was set to 200 mm hg and the connector was moved, the pressure dropped to 17 mm hg.When the patient simulator was set with a simulated curve (120/80 mm hg) and the connector was moved, the pressure dropped to 23/21 mm hg.The fse was able to replicate the reported issue; the ibp readings dropped inaccurately when the ibp cable connector had been moved during simulated operation.The fse confirmed the reported malfunction.As of today, 15dec2020, philips has not received any indication of further evaluation of the mms, product return, and/or device replacement.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.
 
Manufacturer Narrative
A philips field service engineer (fse) visited the customer site around 20oct2020.The fse performed testing on the mms using a patient simulator.When the patient simulator was set to 200 mm hg and the connector was moved, the pressure dropped to 17 mm hg.When the patient simulator was set with a simulated curve (120/80 mm hg) and the connector was moved, the pressure dropped to 23/21 mm hg.The fse was able to replicate the reported issue; the ibp readings dropped inaccurately when the ibp cable connector had been moved during simulated operation.Philips product support engineering (pse) inspected the returned mms after it had been returned.Pse was also able to replicate the reported issue in the same fashion as the fse, with the pressure dropping to 17 mm hg when moving the connector.Pse also observed external wear and tear from 14 years of use.Pse then observed no issues with the solder connections between the connector and the pressure board.Pse then unsoldered the connector and disconnected it from the pressure board.Two pins were observed to be missing, most likely due to movement of the connector.White residue, possibly from disinfectant residue, was also observed on the solder contacts.Pse found no issues when examining the pressure board itself.Philips fse and pse confirmed the reported malfunction; the ibp readings dropped inaccurately when the ibp cable connector had been moved during simulated operation.After examining the returned mms, pse has observed signs of wear and tear from 14 years of use, which may have resulted in the following possible causes: 1.The loose contact on the two pins (shield and bridge detection) could have caused a short circuit to one of the neighboring pins due to movement of the connector.2.There were internal short circuits inside the battered connector due to connector movement from the sensor cable, which could have led to a voltage dip on the pressure signal.The customer has since been provided a replacement mms (sn (b)(6)).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.
 
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Brand Name
INTELLIVUE MUTLI MEASUREMENT SERVER (MMS)
Type of Device
COMPACT PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key10714302
MDR Text Key212386746
Report Number9610816-2020-00386
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K030038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 10/14/2020
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 NumberM3001A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/14/2020
Initial Date FDA Received10/21/2020
Supplement Dates Manufacturer Received10/14/2020
10/14/2020
Supplement Dates FDA Received12/28/2020
02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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