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

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.

• Brand Name: LIFEPAK 15
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows rd., n.e.; redmond WA 98052
• MDR Report Key: 6442042
• MDR Text Key: 71114487
• Report Number: 6442042
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2017,03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2017
• Event Location: Other
• Date Report to Manufacturer: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1