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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll on 12/07/2015.Investigation results as follows: visual inspection of the returned platform was performed and found no damages on the autopulse platform.A review of the archive showed user advisor 17 (max motor on time exceeded) had occurred on (b)(6) 2015 and ua 7 (discrepancy between load 1 and load 2 too large) had occurred on (b)(6) 2015 thus confirming the reported complaint.The platform was functional tested and found that one of the load cells was at fault.The load cell was replaced to remedy the user advisories.The platform than passed a 17 minutes run-in test with a 95% patient test fixture (lrtf).Based on the investigation, one of the load cell was replaced to remedy the reported user advisories.In summary the customer's reported complaint that the platform prompted ua 7 and ua 17 was confirmed during archive review.The root cause for the ua 7 and ua 17 was a defective load cell.The user advisories are designed into the autopulse platform.Ua 2 alerts the user that a misalignment or inappropriate movement of the patient or the lifeband has occurred.This condition is typically correctable by the operator.Ua 17 alerts the user that there is hardware or software issues or the load cells are damaged.The platform passed all initial and final functional testing criteria.

Event Description

Customer reported that during the morning shift check, the autopulse platform s/n (b)(4) displayed user advisory (ua) 7 (discrepancy between load 1 and load 2 too large).The customer re-aligned the mannequin.Customer also stated that the platform also displayed ua 17 (max motor on time exceeded during active operation) once.There was no patient involvement during this event.No further information was provided.

• 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: 5319159
• MDR Text Key: 34143233
• Report Number: 3010617000-2015-00693
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 12/01/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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