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

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 12/10/2020

Event Type  malfunction  

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 Description

The customer contacted physio-control to report that their device charging accessory electrocuted and cause one of their employee's to be hospitalized.

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 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
• 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: 11725319
• MDR Text Key: 247299490
• Report Number: 0003015876-2021-00921
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873994429
• UDI-Public: 00883873994429
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: 99577-001396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization