MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 ASSY,LP EXPRESS, SEMI, AHA 2005, DUTCH; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number EXPRESS

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and verified the reported issue.Physio 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 distributor returned their customer's device to physio-control.During device evaluation, physio observed that the device showed the charge-pak, attention, and service wrench icons in its readiness display.With the three icons in the readiness display, the device's batteries might be at a very low state of charge, and defibrillation therapy might not be delivered if needed.There was no report of patient use being associated with the reported event.

Manufacturer Narrative

Physio-control further evaluated the customer's device.It was observed that the internal hlc batteries had previously depleted to a low state; however during testing, the device appeared to power on normally.The cause of the reported device issue could not be determined.The customer was sent a replacement.

Event Description

The distributor returned their customer's device to physio-control.Upon, device evaluation, physio observed that the device showed the charge-pak, attention, and service wrench icons in its readiness display.With the three icons in the readiness display, the device's batteries might be at a very low state of charge, and defibrillation therapy might not be delivered if needed.There was no report of patient use being associated with the reported event.

• Brand Name: ASSY,LP EXPRESS, SEMI, AHA 2005, DUTCH
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052 9706
• Manufacturer Contact: meg marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7156235
• MDR Text Key: 96119342
• Report Number: 3015876-2017-01676
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K033275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EXPRESS
• Device Catalogue Number: 99427-000135
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: No
• Device Age: 4 YR
• Event Location: Other
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1