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

Model Number MODEL 100

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn: (b)(4)) powering off during use was confirmed during initial functional testing and review of the retrieved archived data.The root cause of the issue could not be determined through these evaluation.Initial functional testing could not be performed, the platform failed during take-up and then powered off.Review of the archive data revealed multiple fault 16 (timeout moving to take-up position) messages and automatic shut-off had occurred on the reported event data, (b)(6) 2017.Upon further evaluation of the platform, it was observed the platform had no brake activation, therefore causing a clicking sound when the platform was powered on.Additionally, it was found that the drive train motor had corrosion at the brake housing area.Typically in warm and humid climate, the drive train motor brake will seize due to corrosion if the platform is not powered on daily/frequently.Based on the archive data, the platform had not been powered on from (b)(6).Consequently, this will contribute to the fault 16 and will prevent the platform from providing compressions.To prevent this issue from reoccurring the corrosion was cleaned off and the brake gap readjusted.Normal brake activation was achieved.The platform passed final functional testing with no faults or error found.Additional repairs were completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue.The cracked front cover observed during visual inspection was replaced and a clutch plate deburring was performed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).The platform passed all final testing criteria.

Event Description

As reported during patient use, when the autopulse platform (sn: (b)(4)) was powered on, and the responding crew tried to adjust the lifeband, the platform powered off.The customer tried to replace the lifeband; however, the same issue persisted.According to the reporter, there was no error message displayed.The responding crew ultimately reverted to manual cpr.The reporter indicated there were no adverse effects to the patient as a result of the issue.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6875845
• MDR Text Key: 86610404
• Report Number: 3010617000-2017-00709
• 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,user faci
• Reporter Occupation: Paramedic
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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