MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number CR2

Device Problems No Audible Prompt/Feedback (2282); Component Missing (2306); Battery Problem (2885); Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The customer will be provided with a replacement device.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 Description

A customer contacted physio-control to report that their device would not provide audio voice prompts.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no patient use associated with the reported event.

Event Description

A customer contacted physio-control to report that their device would not provide audio voice prompts.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no patient use associated with the reported event.

Manufacturer Narrative

Stryker evaluated the device at the product analysis center (pac) and confirmed the reported issue of improper lid operation.A root cause of the reported issue was determined to be due to the missing magnet in lid.The customer is provided with the new lid.

Manufacturer Narrative

Section f10 device code grid of the supplemental medwatch report indicated: component missing section f10 device code grid of the supplemental medwatch report should indicate: detachment of device or device component section h6 results code grid of the supplemental medwatch report indicated: operational problem identified section h6 results code grid of the supplemental medwatch report should indicate: incorrect dimension section h6 conclusion code grid of the supplemental medwatch report indicated: cause traced to manufacturing section h6 conclusion code grid of the supplemental medwatch report should indicate: cause traced to component failure.

Event Description

A customer contacted physio-control to report that their device would not provide audio voice prompts.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no patient use associated with the reported event.

Event Description

A customer contacted physio-control to report that their device would not provide audio voice prompts.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no patient use associated with the reported event.

Manufacturer Narrative

Section h10 additional mfg narrative of the supplemental medwatch report indicated: physio- control evaluated the device at the product analysis center (pac) and confirmed the reported issue of improper lid operation.A root cause of the reported issue was determined to be due to the missing magnet in lid.The customer is provided with the new lid.Section h10 additional mfg narrative of the supplemental medwatch report should indicate: physio- control evaluated the device at the product analysis center (pac) and confirmed the reported issue of improper lid operation.A root cause of the reported issue was determined to be due to the missing magnet in lid.The device was archived by physio-control.The customer was provided with a new device.An engineering investigation has determined that due to the design of the lcpr2 lid switch, absence of the lid magnet allows current to flow from the battery, even when the device is in standby mode.This will reduce the life of the battery.Therefore, the reported issue, the loss of lid/lid magnet, is associated with two hazardous situations: opening the lid does not turn on the device, and, higher than intended current draw while the device is in standby mode results in a prematurely depleted the battery.Replacement of the device lid so that the magnet is present in the device allows the lid switch to function as designed; turning on/off the device when the lid is opened and preventing current draw when the device lid is closed.The lpcr2 operating instructions has been updated to include additional troubleshooting tips to direct the customer to act when device behavior indicates the lid magnet may be missing.A new warning informs the customer of the risk associated with a missing magnet.

• Brand Name: LIFEPAK(R) CR2 DEFIBRILLATOR
• 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: 10435426
• MDR Text Key: 203817740
• Report Number: 0003015876-2020-01113
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-000234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3015876-01/14/2021-001-C
• Patient Sequence Number: 1