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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (b)(4) was returned for evaluation.The customer reported complaint for the platform displaying "system error, out of service, revert to manual cpr" was confirmed during functional testing.The root cause was found to be due to defective processor board.The processor board was replaced to remedy the fault.In previous service repair on (b)(6) 2017 the platform passed functional testing before being returned to customer and was unrelated to the reported complaint.Visual inspection of the returned platform was performed and no physical damage was noted.No discrepancies were found in the archive data.During the initial functional testing, the platform could not be powered on.After disconnecting and reconnecting the power switch, the platform work as intended.The platform has passed all the functional testing criteria.

Event Description

It was reported that during shift check, the autopulse platform (b)(4) was not powering up.The customer tried to use multiple li-ion batteries; however, the platform did not power on.The customer just received the platform from service.No other information was provided.

Manufacturer Narrative

The customer reported complaint was confirmed during the initial functional testing.The power switch cable was replaced in order to avoid the re-occurrence of the reported complaint.No physical damage was noted during visual inspection.No discrepancies were found in the archive data.The platform did not power on during the initial functional testing; however, after disconnecting and reconnecting the power switch cable, the platform worked as intended for use.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).

• 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: 6584217
• MDR Text Key: 75857901
• Report Number: 3010617000-2017-00378
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• 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: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2008
• 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