MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LP15,EN,SPO2,3L/12L,EX,NIBP,CO2,TR,VR,BT,TMP,V4; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control will contact the customer to request additional information on the patient.Physio-control evaluated the customers device and was unable to duplicate the reported issue.The power cord accessory was replaced by the customer as a precaution.
Event or Problem Description
The customer contacted physio-control to report that their device charging accessory electrocuted and cause one of their employee's to be hospitalized.
Additional Manufacturer Narrative
Physio-control received additional patient information from the customer.It was reported that the operator experienced an unintended electrical shock while using the lp15 battery charger base, operator received an electric shock while touching the power cord.It was reported the affected user "is fine now", therefor no serious injury has been reported to physio-control.
Event or Problem Description
The customer contacted physio-control to report that their device charging accessory electrocuted and cause one of their employee's to be hospitalized.

• Brand Name: LP15,EN,SPO2,3L/12L,EX,NIBP,CO2,TR,VR,BT,TMP,V4
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11725319
• Report Number: 0003015876-2021-00921
• Device Sequence Number: 3894773
• Product Code: MKJ
• UDI-Device Identifier: 00883873994429
• UDI-Public: 00883873994429
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization