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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform for evaluation yet.When the product is returned.A supplemental report will be filed if the evaluation is completed.

Event Description

During shift check, the autopulse platform ((b)(4)) displayed "system error, out of service, revert to manual cpr".There was no patient involvement.

Manufacturer Narrative

The customer reported complaint for the autopulse platform displaying an error message "system error, out of service, revert to manual cpr" was confirmed during initial functional testing.The root cause was due to a defective processor board.The autopulse platform is a reusable device and was manufactured in 2007 and is 11 years old, well beyond the expected service life of five years.Due to the age of the device this platform will be scrapped.No physical damage was observed during visual inspection.The platform failed the initial functional testing due to the error message "system error, out of service, revert to manual cpr" during power up.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaints for autopulse sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 7449396
• MDR Text Key: 106307268
• Report Number: 3010617000-2018-00460
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/21/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1