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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 11/12/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n: (b)(4)) was returned for evaluation.The customer reported complaint of the platform displaying error message ua 16 (timeout moving to take-up position) and ua 02 (compression tracking error) was confirmed during archive review and initial functional testing.During archive review, multiple user advisory (ua) 16 (timeout moving to take-up position) and one user advisory (ua) 02 (compression tracking error) was noted on the reported date of (b)(6) 2016.The archive also indicated that the customer does not perform daily shift check on the platform.2-3 weeks gap was noted before the platform was powered on.Per zoll autopulse user guide, it is recommended to perform daily check to ensure that the autopulse system is in a state of readiness to perform chest compressions.Initial functional testing of the platform could not be performed due to ua 16 (timeout moving to take-up position) was displayed when the unit was powered on.The break gap was found to be seized.The root cause of the ua 16 (timeout moving to take-up position) error message was due to seized break gap.The break gap was cleaned with alcohol and readjusted to remedy the complaint.Ua 02 (compression tracking error) error message was not observed after the ua16 (timeout moving to take-up position) was cleared.The platform was run for 15 minutes with lrtf with no faults.The autopulse also passed load cell characterization test, both load cells are within specifications.The autopulse has passed all final testing.No visual damage was noted during visual inspection.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).

Event Description

It was reported that during pr event, the demo autopulse platform (sn: (b)(4)) was displaying error message user advisory 16 (timeout moving to take-up position) and the lifeband did not retract.The customer tried to replace the lifeband and batteries; however the error message persisted.The customer also tried to pull up the lifeband without any success.Error message user advisory 02 (compression tracking error) was also noted.No patient involvement was reported.

• 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: 6207759
• MDR Text Key: 63370332
• Report Number: 3010617000-2016-00948
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/27/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2008
• 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