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

Model Number MODEL 100

Device Problems Component Missing (2306); Device Displays Incorrect Message (2591)

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

Event Date 02/09/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse platform displayed user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) and ua 11 (max patient temperature exceeded) messages.It was also reported that the load plate screws were missing.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/19/2015 for investigation.Investigation results as follows: visual inspection was performed and 2 missing screws from the front enclosure were observed.The battery lock pin was also found to be have been broken.Both front and bottom enclosures were also damaged.From the condition of the returned unit, the damages appear to have been due to wear and tear.When the platform was powered up for functional testing, the reported user advisory (ua) 7 code (discrepancy between load 1 and load 2 too large) was observed.However, the reported ua 11 code (max patient temperature exceeded) was not duplicated during functional testing.Further inspection of the platform identified the cause of the ua 7 to be a single point load cell connected to the j2 connector, which was not functioning properly.No mechanical issues were identified that may have caused or contributed to the reported ua 11 code.The platform's archive was reviewed and there were no user advisory codes observed on the reported event date.Multiple ua 7 codes were observed on (b)(6) 2015.Previous inspection identified that the cause of the ua 7 code was a single point load cell, which was not functioning properly.The archive did not show any ua 11 codes occurring with this platform.Based on the investigation, the parts identified for replacement were the single point load cell, front enclosure, bottom enclosure and broken battery lock pin.In summary, the reported issue of the platform missing load plate screws was confirmed during visual inspection and attributed to wear and tear.The reported complaint of the platform displaying a ua 7 code was confirmed during functional testing as well as platform archive review.Based on inspection of the device, the cause was identified as a single point load cell that was not functioning properly.The reported ua 11 could not be duplicated during functional evaluation nor was the code seen in the platform's archive.Following service, the device 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: 4579234
• MDR Text Key: 5338724
• Report Number: 3010617000-2015-00139
• 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
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• 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: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2007
• 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