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

Model Number 15

Device Problems No Display/Image (1183); Loss of Power (1475)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Though stryker requested some patient information, stryker will not request any information which can identify, directly or indirectly, a person to be in accordance with regulation (eu) (b)(4) of the (b)(6) parliament and of the council.Due to character limitations, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).A stryker service representative performed an initial evaluation of the customer¿s device and was able to verify the reported issue.The cause of the reported issue was isolated to the system pcb assembly, however further root cause could not be determined.The device can not be repaired.The customer has been provided with a replacement device.

Event Description

A customer contacted stryker to report that their device had a blank display during intervention on a patient.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

Manufacturer Narrative

Section h10 additional mfg narrative of the initial medwatch report indicated: no display/image.Section h10 additional mfg narrative of the initial medwatch report should indicate: loss of power.

Event Description

A customer contacted stryker to report that their device had a blank display during intervention on a patient.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 14119588
• MDR Text Key: 289429137
• Report Number: 0003015876-2022-00577
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

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
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 08/29/2022
• Supplement Dates FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1