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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

During deployment the autopulse platform (sn (b)(4)) displayed a "system error, out of service, revert to manual cpr" message upon power up.Manual cpr was immediately performed.No known impact or consequence to patient.

Manufacturer Narrative

The reported event was not reproduced during functional testing of the autopulse platform (sn (b)(4); however, confirmed during archive review.Review of the archive data retrieved from the platform revealed a system error 139 (unable to hold compression position) error message; the root cause was due to the defective drive train motor brake assembly air gap being out of specification.After readjustment of the brake gap to specification, the platform was functionally tested including the load characterization check and passed the testing.The platform operated with continuous compression without any issues or error messages observed.As part of routine service during testing, the platform was examined and found physical damage on the short black cover and the drive shaft exhibits binding and resistance.These observations are unrelated to 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 (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7559131
• MDR Text Key: 109760247
• Report Number: 3010617000-2018-00586
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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: 05/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1