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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform s/n (b)(4) in complaint was returned to azm (zoll service (b)(4)) for investigation on (b)(6) 2015.Visual inspection: during visual inspection the rotation shaft was "sticky", no other issues or discrepancies were found.Archive analyses: in a review of the archive data log several user advisories (ua) were found on the reported date.Ua 2 (compression tracking error), ua 17 (max motor on time exceeded during active operation), and ua 139 (unable to hold compression position).This confirms the reported complaint of the customer receiving a system error.Other user advisory codes were seen, however there were not on the reported event date ((b)(6)2015).Functional testing: during functional testing it was found that the break gap was out of specification.The possible cause of ua 139 (unable to hold compression position) is a brake gap issue or drive train issue.To remedy ua139, the brake gap was adjusted.Based on the investigation, to remedy the observation of the sticky shaft rotation, deburring of the clutch plate was performed.In addition the break gap was adjusted which resolved the user advisory 139 error.After these resolutions were performed, the system returned to normal functionality.In summary: the reported complaint of the autopulse platform displaying a system error which was confirmed in the archive data log review.In addition during functional testing it was also observed that the brake gap was out of specification, which would cause the platform to display a system error (ua 139).During functional testing it was observed that the shaft rotation was sticky which was resolved by deburring the clutch plate.After the adjustment to the brake gap and the deburring of the clutch plate the autopulse platform passed all final functional testing and performed as intended.

Event Description

Customer reported that during a shift check the autopulse platform s/n (b)(4) displayed an error.No patient involved at the time of this event.No further information was provided.

• 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: 5316746
• MDR Text Key: 34075791
• Report Number: 3010617000-2015-00691
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/30/2015

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/21/2015
• 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