MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES); Dc-Defibrillator, Low-Energy (Including Paddles)

Catalog Number	11131-000001
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted stryker to report that their device would not deliver defibrillation energy when used with internal paddles.As a result, defibrillation therapy would not be available, if needed.There were no adverse effects to the patient as a result of the reported event.
Additional Manufacturer Narrative
Stryker 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.Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.

• Brand Name: LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
• Common Device Name: Dc-Defibrillator, Low-Energy (Including Paddles)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): Physio-Control, Inc. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 25313231
• Report Number: 0003015876-2026-01082
• Device Sequence Number: 20191684
• Product Code: LDD
• UDI-Device Identifier: 00883873824702
• UDI-Public: 00883873824702
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K895379
• 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): 09/23/2026

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: Health Professional
• Device Catalogue Number: 11131-000001
• Device Lot Number: 3317813-007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK 20 DEFIBRILLATOR/MONITOR, MKJ
• Patient Sex: Unknown