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

Model Number 15

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer provided a printout of the code summary and physio-control performed a clinical evaluation.Physio determined that the cause of the reported issue was due to use error.The patient was cardioverted from monomorphic ventricular tachycardia to ventricular fibrillation.One use error did occur.The user failed to synchronize the triangular marker with the middle (peak) of the ventricular complex.The device was not returned to physio-control for an evaluation.Device not evaluated by manufacturer.

Event Description

The customer contacted physio-control to report that a gentleman presented with monomorphic v-tach and chest pain.The staff performed synchronized cardioversion at 100 joules but the patient subsequently transitioned to ventricular fibrillation.The doctor felt that the device was synchronizing at the end of the qrs complex resulting in a shock delivery during the relative refractory period resulting in the subsequent unstable arrhythmia.There was no report of an adverse outcome to the patient as a result of the reported issue.No further details about the patient or the event were provided.Physio-control has contacted the customer in order to obtain additional information on the patient; however, no response has been received.

Manufacturer Narrative

Physio-control received the following patient information from the customer: (patient identifier) indicates: (b)(6).(age at time of event) indicates: 71 years.(gender) indicates: male.(weight) indicates: 101 kgs.(other relevant history) indicates: hyperlipidemia, hypertension, sleep apnea treated with nocturnal bipap.

Event Description

The customer contacted physio-control to report that a gentleman presented with monomorphic v-tach and chest pain.The staff performed synchronized cardioversion at 100 joules but the patient subsequently transitioned to ventricular fibrillation.The doctor felt that the device was synchronizing at the end of the qrs complex resulting in a shock delivery during the relative refractory period resulting in the subsequent unstable arrhythmia.There was no report of an adverse outcome to the patient as a result of the reported issue.No further details about the patient or the event were provided.Physio-control has contacted the customer in order to obtain additional information on the patient; however, no response has been received.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• 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: 8672436
• MDR Text Key: 147152325
• Report Number: 0003015876-2019-00983
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: UNK_SMP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 101