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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the zoll platform in complaint for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

As reported, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 17 (max motor on time exceeded during active operation) error message after 2-7 compressions.Unknown if the device issue was observed during the patient use or device check.No known impact or patient consequence was reported.No further information was provided.

Manufacturer Narrative

The customer reported complaint for the autopulse platform stopped compressions and displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) error message was confirmed during archive review and not during initial functional testing.There were no device deficiencies found during evaluation of the returned console that could have caused or contributed to the reported complaint.Visual inspection was performed and found damaged load plate cover on the autopulse platform, unrelated to the reported complaint.This type of damage can occur likely due to mishandling.Review of the archive data indicated user advisory (ua) 17 errors occurred on the reported event date, thus confirming customer complaint.Base on the archive, the autopulse platform performed 256 compressions on the medium size patient.The device has stopped compressing due to (ua) 17.The user pressed restart to clear the fault and the autopulse platform was used again and stopped three more time due to (ua) 17.The user advisory (ua) 17 error message alerts the user that the drive motor did not reach the target compression depth within specification when used on a medium/large size stiff patient or when the battery being used has a low voltage or the lifeband is twisted.The reason the autopulse platform stops after a few compressions, it is trying to build up to the 20% compression depth and cannot do it in the specific time frame but did not have enough power to achieve this compression rate within 0.38 seconds.The lifeband was not returned for evaluation.The brake gap inspection was performed and verified the gap was within the specification.The platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to the 250-pound patient and passed all functional testing criteria and met all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform with serial number (b)(4).Reported on (b)(6) 2018.Defective cable was replaced to remedy 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
• MDR Report Key: 8135899
• MDR Text Key: 129474137
• Report Number: 3010617000-2018-01234
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• 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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1