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 Issue (2379); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for investigation.Investigation results as follows: device history record (dhr) was reviewed and no similar complaints were reported for autopulse with serial number (b)(4).Visual inspection of the returned platform was performed; top cover wire stand was noted to be damaged.Autopulse 1.5 is a reusable device and was manufactured in 09/28/08.The damage found is characteristic of normal wear and tear for the life of the device.A review of the archive was performed and archive data indicated user advisory (ua) 16 (timeout moving to take up-position) and ua 7 (discrepancy between load1 and load2 too large) which is unrelated to the reported complaint.Functional testing was performed on the device and device passed functional test without any fault or error message.In summary the customer's reported complaint is confirmed during visual inspection.The physical damages found during visual inspection can occur due to normal wear and tear and/or physical abuse.The root cause for the observed user advisory codes cannot be determined.The brake gap inspection was performed and verified to be within the specification.Load cell characterization testing was performed and confirmed to be functioning within the specification.Run in test with the 95% patient test fixture (lrtf) was performed for several hours, the autopulse passed all the tests and meet all the required specification without duplicating any error messages.

Event Description

It was originally reported, by the biomed engineer that the autopulse platform's (s/n (b)(4)) head restraints were broken and needed replacing.When the device was received at zoll for repair, the archive log was reviewed and user advisories (ua) 16 (timeout moving to take up-position) and ua 7 (discrepancy between load1 and load2 too large) were observed.User advisories are considered reportable events, therefore the complaint was changed to a reportable event based on the investigation.There was no patient involved during this event.

• 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: 5657503
• MDR Text Key: 45248276
• Report Number: 3010617000-2016-00332
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/16/2016

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: 02/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2008
• 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