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

Model Number MODEL 100

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll for investigation on (b)(6) 2015.Investigation results as follows: visual inspection of the returned platform was performed and found that the head restraint wire was cut/broken, thus confirming the customer's reported complaint.The front enclosure was also observed to be cracked and the battery lock was bent.From the condition of the platform, the damages appear to have been caused by normal wear and tear.A review of the platform's archive data was performed and no user advisories or warnings were observed on the initial reported event date of (b)(6) 2015.Functional evaluation of the returned platform was performed and the customer's reported complaint of the driveshaft being difficult to operate was observed.The clutch plate was deburred to address this issue.In addition, it was observed that the autopulse lifeband was falling off because it was unable to lock in place.The channel roller assembly was found to be at fault.Following replacement of the channel roller assembly and deburring of the clutch plate, the platform passed all functional testing.Based on the investigation, the parts identified for replacement were the top cover, front enclosure, battery lock, and the channel roller assembly.In summary, the customer's reported complaint of the right shoulder attachment wire being broken was confirmed through visual inspection.The top cover was replaced to remedy this reported complaint.The reported complaint of the driveshaft being difficult to rotate was also confirmed and is attributed to the clutch plate needing to be deburred.Unrelated to the reported complaint, the lifeband falling off during functional testing was due to the channel roller assembly not functioning properly.The additional physical damages found during visual inspection are unrelated to the reported complaint.The platform is a reusable device and therefore, these types of physical damages can occur due to normal wear and tear and/or physical abuse.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

Event Description

It was reported that the right restraint wire, where the shoulder restraint attaches was broken.The customer also reported that the drive shaft was slow to operate.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During evaluation, it was observed that the lifeband kept falling off and was unable to lock into place.Although the customer did not report this, a loose lifeband issue is considered a reportable malfunction.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 5109609
• MDR Text Key: 26939997
• Report Number: 3010617000-2015-00531
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Health Professional
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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