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 Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 01/16/2015

Event Type  malfunction  

Event Description

It was reported that during patient care, the autopulse platform reset itself several times.Customer also reported that grinding noises were heard when the autopulse platform was turned on.No adverse patient sequelae was reported.After patient care, the customer tested the platform by turning the device on.Upon power on, the platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/21/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform found that the top cover at load cell amp board connector, j1 was cracked.The physical damage found during visual inspection is not related to the reported complaints that the autopulse platform reset itself several times, that grinding noises were heard when the platform was turned on and that the platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.The damage appears to have been caused by normal wear and tear (autopulse manufactured in may of 2007).A review of the autopulse platform's archive data was performed and the reported complaint of a ua 45 fault was confirmed.The archive data showed that multiple ua 45 messages occurred on the reported event date.Initial functional testing was performed and the reported complaints could not be reproduced.The platform ran for 30 minutes using a large resuscitation test fixture (lrtf), equivalent to a 250 pound patient and an additional 15 minutes using a test manikin with no problems observed.Based on the investigation, the part identified for replacement was the top cover.In summary, the reported complaint that the autopulse platform reset itself several times and that grinding noises were heard when the platform was turned on was not confirmed during functional testing.The reported complaints could not be reproduced and the platform passed the initial functional testing.The reported complaint of a ua 45 fault was confirmed based on the platform archive review but was not reproduced during testing.The root cause for the ua 45 fault could not be determined.Per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.The physical damage found during visual inspection is unrelated to the reported complaints.The top cover was replaced to remedy the observed physical damage.Upon replacement of the damaged part, the platform was re-evaluated through functional testing and passed all testing criteria.

• 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: 4505348
• MDR Text Key: 16174784
• Report Number: 3010617000-2015-00082
• 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: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2007
• 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