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

Model Number	CRPLUS
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer received a replacement device.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted physio-control to report that during a patient event, their device would not detect that a patient was connected.The device gave a "connect electrodes" message even though the patient was connected to the device.Medical personnel removed the electrodes from the device and placed them into a backup device when ems arrived on scene.There was no adverse effects to the (b)(6) year old patient as a result of the reported issue as the backup device was used to continue patient care.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.The therapy harness connection to the upper case was not connected (manufacturing error), and a patient load could not be recognized.
Event or Problem Description
The customer contacted physio-control to report that during a patient event, their device would not detect that a patient was connected.The device gave a "connect electrodes" message even though the patient was connected to the device.Medical personnel removed the electrodes from the device and placed them into a backup device when ems arrived on scene.There was no adverse effects to the (b)(6) patient as a result of the reported issue as the backup device was used to continue patient care.

• Brand Name: LIFEPAK CR® PLUS DEFIBRILLATOR
• 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: 7589261
• Report Number: 0003015876-2018-00909
• Device Sequence Number: 1261754
• Product Code: MKJ
• UDI-Device Identifier: 00885074440323
• UDI-Public: 00885074440323
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: CRPLUS
• Device Catalogue Number: 99403-000156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 68