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

Model Number MODEL 100

Device Problems Break (1069); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

It was reported that during a shift rotation, the autopulse platform did not power up.Customer also stated that the battery compartment was damaged.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/08/2015 for investigation.Investigation results as follows: visual inspection of the returned platform showed that the battery connector of the power distribution board (pdb) at j2 and the encoder cover were damaged.The damaged battery connector of the pdb found during visual inspection confirmed the reported complaint of the platform not powering up.The physical damages appear to have been caused by normal wear and tear (autopulse manufactured in 08/2004).A review of the autopulse platform's archive was performed and showed that no sessions occurred on the reported event date of (b)(6) 2015.However, the archive showed that multiple user advisory (ua) 3 (error communicating with battery controller) occurred on (b)(6) 2014.Functional testing was performed using a test pdb and the reported complaint was not reproduced.The platform ran with a test manikin for approximately 7 minutes and no problems were observed.Based on the investigation, the parts identified for replacement were the pdb and the encoder cover.In summary, the reported complaint of the platform not powering up was confirmed based on the platform's archive review and during visual inspection.The fault was found to be due to the damaged battery connector of the pdb.The ua 3 fault observed in the archive review was found to be due to the damaged battery connector, which likely contributed to the platform not powering on.The damaged encoder cover found during visual inspection is unrelated to the reported complaint.Upon replacement of all parts, 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: 4467000
• MDR Text Key: 5400253
• Report Number: 3010617000-2015-00056
• 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: 01/05/2015

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: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2004
• 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