MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the platform did not start compressions was confirmed during the review of the archive and functional testing.Following service, including replacement of the power distribution board (pdb), the top cover, encoder cover, motor cover, and head restraint brackets, the platform was further tested and passed all testing with no issue or faults observed.The device failed functional testing, due to ua29 (loss of brake connectivity) that occurred upon pressing of the start button, thus confirming the reported complaint.The fault was found to be due to the defective power distribution board (pdb).Visual inspection of the returned autopulse platform was performed and found top cover, encoder cover, motor cover and head restraint brackets damaged, thus confirming the reported complaint of the crack on the top cover and the left hand side of the platform is loose.The autopulse platform is a reusable as well as serviceable device and was manufactured on 01/2007.Therefore, this type of physical damages found during visual inspection are characteristics of normal wear and tear for the life of the device.The platform has exceeded its expected service life of 5 years.Review of archive data confirmed multiple ua29 errors on the reported event date, thus confirming the reported complaint.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number 12547.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.For a trained user, changing from the autopulse to manual cpr can be made quickly, and patient's outcome should not be negatively impacted when compared to standard of care manual cpr.In this case, autopulse did not start and did not provide and compression.It is not known if the crew reverted to manual cpr.Rosc was not achieved.No detail was provided for the patient other than that the patient had been down for a long time.However, the patient's death is most likely caused by the underlying condition of the patient.

Event Description

As reported, during patient call the autopulse platform (sn (b)(4)) was power up and patient was aligned, however, the platform did not start compressions.According to the customer the patient had been down for a long time and did not achieve rosc.Customer stated that platform did not attributed to the patient death.In addition customer reported the device has a crack on the top cover and the left hand side of the platform is loose.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7102483
• MDR Text Key: 94984057
• Report Number: 3010617000-2017-01112
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/06/2017

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: MODEL 100
• Device Catalogue Number: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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