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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 07/09/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that during use on a mannequin, the autopulse platform displayed a "realign patient/mannequin" message.Customer indicated that the platform did not properly perform take-up of the autopulse lifeband.The lifeband did not take-up equal slack in the bands (more slack from one side of the band is taken up compared to the other side).After the message displayed on the platform, customer checked the alignment of the mannequin but the issue did not resolve.Customer indicated that they used the same mannequin on other platforms and did not encounter any issues.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Investigation results for the returned platform are as follows: visual inspection of the returned platform was performed and found that both patient head restraint brackets were cracked.The physical damages found during visual inspection are unrelated to the customer's reported complaint of the platform displaying a "realign patient" message.A review of the platform's archive data was performed and revealed that the archive data was partially corrupted.Data on and around the reported event date of (b)(4) 2015 could not be retrieved.Therefore, the customer's reported complaint could not be confirmed through review of the platform's archive data.The customer's reported complaint that the platform did not properly perform take-up of the autopulse platform was confirmed when a user advisory (ua) 18 (max take-up revolutions exceeded) message displayed within the first compression.The platform failed initial functional testing due to the ua 18 message.A load cell characterization test was performed, which confirmed that both load cell modules were defective and under-reporting values.It should be noted that a ua 18 requires users to pull up on the lifeband and check patient alignment.Based on the investigation, the parts identified for replacement were both load cell modules and both patient head restraint brackets.In summary, the customer's reported complaint was confirmed during functional testing when the platform displayed a ua 18 message within the first compression.It should be noted that a ua 18 requires users to pull up on the lifeband and check patient alignment.The root cause of the ua 18 was determined to be defective load cells.The physical damages found during visual inspection are unrelated to the customer's reported complaint.The autopulse is a reusable device and therefore, these types of physical damage can occur due to normal wear and tear and/or physical abuse.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4951129
• MDR Text Key: 23129758
• Report Number: 3010617000-2015-00422
• Device Sequence Number: 1
• Product Code: DRM
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2006
• 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