MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Failure to Sense (1559)

Patient Problems Brain Injury (2219); No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted stryker to report that when their device was used to monitor a patient's functional oxygen saturation, the spo2 function went out after a while.This resulted in the healthcare providers missing that the level had dropped to 40%.The patient had suffered hypoxic brain damage.

Manufacturer Narrative

The customer confirmed that the healthcare providers do not believe the device use contributed to the patient outcome.The following fields from the initial medwatch report were updated accordingly: adverse event/product problem: product problem.Outcomes attributed to ae: blank.Type of reportable event: malfunction.Physio-control evaluated the customer's device and returned spo2 sensor and was unable to reproduce or verify the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.

Event Description

The customer contacted stryker to report that when their device was used to monitor a patient's functional oxygen saturation, the spo2 function went out after a while.This resulted in the healthcare providers missing that the level had dropped to 40%.The patient had suffered hypoxic brain damage.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 8978055
• MDR Text Key: 157040120
• Report Number: 0003015876-2019-01511
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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 Number: 15
• Device Catalogue Number: 99577-001501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 36 YR