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

Model Number MODEL 100

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

It was initially reported that the right head restraint on the autopulse platform was missing.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 34 (encoder failure) message.Although the customer did not report this, ua 34 is considered to be a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and the reported complaint was confirmed; the top cover, bottom enclosure and battery lock were damaged.A user advisory 34 (encoder failure) was observed during power up of the platform.Further inspection of the device identified the cause to be that the integrated encoder gearbox was not connected to the processor board.The encoder gearbox was re-connected to remedy this issue.The platform was then run with a test mannequin for 10 minutes and no problems were observed.A review of the platform archive was performed and no user advisories were observed on the reported event date of (b)(6) 2014.Based on the archive, the last date that the platform was used in the field was (b)(6) 2014.The ua 34 code that was previously observed during functional testing was seen in the archive as occurring on (b)(6) 2014 and (b)(6) 2014.Since no other ua 34 codes were seen in the archive, it is likely that the encoder gearbox became disconnected on or around (b)(6) 2014 leading to the ua being displayed.The most probable cause for it becoming disconnected is mechanical impact sustained during use by the customer.Based on the investigation, the part(s) identified for replacement were the following: the top cover, bottom enclosure and battery lock.In summary, the reported complaint of the patient head restraint wire being missing was confirmed during visual inspection and was attributed to wear and tear.Unrelated to the reported event, a ua 34 fault was observed during functional evaluation and is attributed to the integrated encoder gearbox becoming disconnected from the processor board.The archive data showed that a ua 34 code occurred for the first time in the field on (b)(6) 2014 and there were no previous occurrences of this code.Therefore, it appears that the gearbox became disconnected on this day leading to the ua 34 being displayed.The probable cause of it becoming disconnected was identified as being sue to mechanical impact sustained during use by the customer.Following service, including replacement of the damaged parts, the device passed all testing criteria.

Manufacturer Narrative

Please note that corrections were made to the following sections.Please note that the following statement: "a review of the platform archive was performed and no user advisories were observed on the reported event of (b)(6) 2014" on the initial report is incorrect.The initial reported event date is actually unknown.

• 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: 4542789
• MDR Text Key: 16076332
• Report Number: 3010617000-2015-00128
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2007
• 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