• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFEPAK 15 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHYSIO-CONTROL, INC. LIFEPAK 15 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2017
Event Type  malfunction  
Event Description
This month, during a respiratory failure patient transport and near the end of the run, the paramedic/emergency medical technician (emt) had found that no blood pressures (bp) were done. The emt believed he/she had set up the bp correctly, placing cuff on the patient, and pressed the nibp. Emt believed he/she heard the pump engage. Biomed received the lifepak 15 and they were not able to duplicate the issue. Last month, there was a similar event. The ambulance crew was working on a cardiac arrest patient. They were transporting a persistent v-fib patient enroute to the hospital and they did a rhythm check and had a pulse. When the crew member put the blood pressure on and cycled the cuff, the reading was xxx/xx, the crew member tried again with the same result. The crew member reported not wanting to shut the monitor off because they were in the middle of a cardiac event. The monitor was sent (without being rebooted) to biomed. Biomed inspected the lifepak 15 and they were unable to duplicate the problem. Checked nipb internal leak test. Passed. While the root cause was not identified; biomed indicated that is a scenario that intermittently occurs with the nibp whereby if the nibp button is pressed a second time before the pump activates and starts to pump, it will cancel the nibp request and a reading will not be taken.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIFEPAK 15
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
PHYSIO-CONTROL, INC.
11811 willows rd., n.e.
redmond WA 98052
MDR Report Key6442042
MDR Text Key71114487
Report Number6442042
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/24/2017,03/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2017
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2017
Event Location Other
Date Report to Manufacturer03/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-