MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 1000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Upon evaluation, physio-control observed that the device had a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy was therefore reduced.The customer will be provided with a replacement device.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

A customer contacted physio-control to report that their device had illuminated its service wrench icon and logged an event code.During device evaluation, physio-control observed that the device had a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy was therefore reduced.There was no patient use associated with the reported event.

Event Description

A customer contacted physio-control to report that their device had illuminated its service wrench icon and logged an event code.During device evaluation, physio-control observed that the device had a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy was therefore reduced.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control failure analysis center further evaluated the customer's device and determined that the cause of the reported issue was due to a therapy harness ferrite bead being set over an integrated circuit, designator u1, on the analog pcb assembly in error during the manufacturing of the device.The incorrectly set therapy harness ferrite bead broke legs 1 and 16 and caused the device to not deliver a shock.

Manufacturer Narrative

Section e1 initial reporter postal code of the initial medwatch report should indicate: 92224.Section d10 returned to manufacturer on of supplemental medwatch report 001 should indicate: 07/12/2019.Section d10 product available to stryker of supplemental medwatch report 001 should indicate: return.

Event Description

A customer contacted physio-control to report that their device had illuminated its service wrench icon and logged an event code.During device evaluation, physio-control observed that the device had a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy was therefore reduced.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 1000 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: 8933278
• MDR Text Key: 155698329
• Report Number: 0003015876-2019-01426
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K122600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

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: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 99425-000105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 10/08/2019; 02/17/2020
• Supplement Dates FDA Received: 11/01/2019; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1