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

Model Number MODEL 100

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform displayed a user advisory (ua) 16 (timeout moving to take-up position) message.When the device was checked the next day, the message did not appear.However, when the platform retracted the autopulse lifeband, a loud screeching noise sounded and the platform powered off.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 12/19/2014 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 was performed and found that the battery connector was damaged, the battery clip was twisted and the front cover was cracked.The physical damages found during visual inspection are unrelated to the reported complaint.The platform failed initial functional testing as it exhibited a user advisory (ua)16 (timeout moving to take-up position).A review of the platform's archive data was performed and found no anomalies the reported event date of (b)(6) 2014.The archive showed that the last recorded usage of this platform was on (b)(6) 2013, at which time, it did exhibit the reported ua 16.The drive train motor was replaced to remedy the customer's reported complaint of the platform exhibiting a ua 16 and making a screeching sound then shutting off while the platform retracted the lifeband.The platform underwent and passed all final functional testing.In summary, the customer's reported complaint of the platform exhibiting a ua 16 was confirmed through both review of the platform's archive data and upon initial functional testing of the platform.The root cause was determined to be a defective drive train motor, which was replaced, remedying the ua 16.The customer's reported complaint of the platform making a loud screeching sound and then shutting down while retracting the lifeband could not be confirmed, as it was unable to be replicated by zoll.The root cause for this to occur was determined to be a bushing inside of the drive train motor that had slipped, which would most likely cause the reported screeching sound.

• 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: 4401072
• MDR Text Key: 5369837
• Report Number: 3010617000-2015-00015
• 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: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• 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: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2007
• 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