MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/02/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Physio-control performed a clinical review of the reported patient event and was unable to determine if the device use contributed to the patient outcome.This was because of insufficient information available, due to the lack of the patient ecg record for the event to determine if the ecg rhythm was shockable.Physio-control continues to investigate the reported issue 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 their device would not power on during a patient event.The customer advised that the battery indicator of the device was flashing but the device would not power on.Another ambulance unit was on the scene and used another device and was able to treat the patient.The customer did not know the delay between the use of the original device and the backup device.After the event when the customer was back at their office, the device displayed ¿ok¿ and the battery was fully charged.They removed the battery to get the battery information, when attempting to reinstall the battery they felt that it was very difficult to slide the battery into the battery compartment.The patient, (b)(6) year old male did not survive.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.Physio observed that the customer's battery was unable to lock easily into the customer's device.Physio determined that the cause of the reported issue was due to the customer's battery, however further cause could not be determined.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The customer was provided with a new battery.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on during a patient event.The customer advised that the battery indicator of the device was flashing but the device would not power on.Another ambulance unit was on the scene and used another device and was able to treat the patient.The customer did not know the delay between the use of the original device and the backup device.After the event when they customer was back at their office, the device displayed ¿ok¿ and the battery was fully charged.They removed the battery to get the battery information, when attempting to reinstall the battery they felt that it was very difficult to slide the battery into the battery compartment.The patient, an 81 year old male did not survive.
Additional Manufacturer Narrative
Death date of the initial medwatch report was blank.Death date of the initial medwatch report should be "(b)(6) 2018".
Event or Problem Description
The customer contacted physio-control to report that their device would not power on during a patient event.The customer advised that the battery indicator of the device was flashing but the device would not power on.Another ambulance unit was on the scene and used another device and was able to treat the patient.The customer did not know the delay between the use of the original device and the backup device.After the event when they customer was back at their office, the device displayed ¿ok¿ and the battery was fully charged.They removed the battery to get the battery information, when attempting to reinstall the battery they felt that it was very difficult to slide the battery into the battery compartment.The patient, an 81 year old male did not survive.
Additional Manufacturer Narrative
Outcomes attributed to the ae of the initial medwatch report was blank.Outcomes attributed to the ae of the initial medwatch report should be "death".
Event or Problem Description
The customer contacted physio-control to report that their device would not power on during a patient event.The customer advised that the battery indicator of the device was flashing but the device would not power on.Another ambulance unit was on the scene and used another device and was able to treat the patient.The customer did not know the delay between the use of the original device and the backup device.After the event when they customer was back at their office, the device displayed ¿ok¿ and the battery was fully charged.They removed the battery to get the battery information, when attempting to reinstall the battery they felt that it was very difficult to slide the battery into the battery compartment.The patient, an 81 year old male did not survive.
Additional Manufacturer Narrative
Section g4 of supplemental medwatch report 002 indicates: 8/20/2019.Section g4 of supplemental medwatch report 002 should indicate: 11/25/2019.Section g4 of this submission will remain 01/14/2020 so as not to create a late submission.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on during a patient event.The customer advised that the battery indicator of the device was flashing but the device would not power on.Another ambulance unit was on the scene and used another device and was able to treat the patient.The customer did not know the delay between the use of the original device and the backup device.After the event when they customer was back at their office, the device displayed ¿ok¿ and the battery was fully charged.They removed the battery to get the battery information, when attempting to reinstall the battery they felt that it was very difficult to slide the battery into the battery compartment.The patient, an 81 year old male did not survive.

• Brand Name: LIFEPAK(R) 1000 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: 7996036
• Report Number: 0003015876-2018-01767
• Device Sequence Number: 203232
• Product Code: MKJ
• UDI-Device Identifier: 00885074698878
• UDI-Public: 00885074698878
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/14/2020

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: 1000
• Device Catalogue Number: 99425-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 08/20/2019; 08/20/2019; 11/25/2019; 01/14/2020
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 08/27/2019; 12/02/2019; 12/03/2019; 01/14/2020
• 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: Death
• Patient Age: 81 YR
• Patient Weight: 102