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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 01/06/2019

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message and the drive shaft hard to rotate to the home position was confirmed during initial functional testing and archive data review.The encoder drive shaft clutch plate is difficult to rotate, exhibits binding and resistance due to the age of the platform.The sticky clutch plate was deburred to address the issue.The autopulse platform passed functional test after drive shaft was rotated to the home position.Visual inspection was performed and found damaged front enclosure, unrelated to the reported complaint.The front enclosure was replaced to address the issue.The autopulse platform is a reusable device and was manufactured in july 2007 and is 11 years old, well beyond the expected service life of five years.Therefore, this type of physical damage is characteristic of normal wear and tear for the life of the device.The archive data review indicated multiple error message (ua) 45 on the reported event date.The platform was further tested using the manikin with lrtf (large resuscitation test fixture) with continuous compressions with a good known test battery for 12 minutes and passed with no issue or faults observed.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

During the call, the autopulse platform (sn (b)(4)) was used on a patient in cardiac arrest.The autopulse platform operated with continuous compressions for the duration of the transport time to the hospital.Upon arrival and transfer, the patient went to cardiac arrest.The autopulse platform was used again but stopped after performing compressions for a minute and prompt the user with "replace battery" message.The second battery was used and the platform was performing compressions as expected, however, the autopulse platform stopped compressions and displayed a user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message.Troubleshooting was attempted by realigning the lifeband and ensuring that the driveshaft is in its home position.The user was unable to clear the error.The drive shaft was hard to rotate to the home position.No known impact or patient consequence information was available.

• 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 ; 4084192957
• MDR Report Key: 8291391
• MDR Text Key: 134600723
• Report Number: 3010617000-2019-00043
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2007
• 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