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 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the zoll platform in complaint for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

The biomed reported that during device check the autopulse platform would not start compressions with manikin lined up correctly.The manikin was re-aligned and platform was restarted several times without success.Additionally, customer noted user advisory (ua) 45 (not at "home" position after power -on/restart) and user advisory (ua) 16 (time out moving to take up position) intermittently.No patient involved with this event.

Manufacturer Narrative

The customer reported complaint for the platform displayed an error message user advisory (ua) 16 (timeout moving to take-up position) was confirmed during archive review and initial functional testing.The root cause was determined to be a defective drive train motor.The archive data review indicated error message user advisory (ua) 16 and (ua) 45 error messages occurred on the reported event date.The customer reported complaint of autopulse displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was confirmed in the archive review.The driveshaft was rotated back to home position prior to the platform evaluation.The likely root cause of the reported (ua) 45 error message was due to user error.Per the autopulse user guide instruction, to clear (ua) 45, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.The user advisory will persist until the driveshaft is returned to its home position.No physical damage was observed during the visual inspection.The platform failed the initial functional testing due to error message user advisory (ua) 16 displayed when the platform was powered on, thus confirming customer complaint.After repair, the autopulse passed functional testing with no issue or faults observed.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported 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
• MDR Report Key: 7559135
• MDR Text Key: 109760713
• Report Number: 3010617000-2018-00584
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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: 06/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1