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

Model Number MODEL 100

Device Problems Device Issue (2379); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse (ap) platform was returned to zoll (b)(4) on 01/13/2016 for investigation.The investigation results are as follow: visual results: during the visual inspection physical damage to the top cover was observed.The heat restraint wire was cut, battery lock clip was damaged and the front enclosure was cracked.Archive data results: during the review of the archive data several user advisory (ua) 45 (not at "home" position after power-on/restart) were observed on (b)(6) 2015, (b)(6) 2016.Ua 45 is related to the lifeband not being able to retract, thus confirming the reported complaint.Functional testing results: during functional testing the platform was ran for 10 minutes using lrtf (large resuscitation test fixture, equivalent to 250 pound patient) with no issue.The ap platform passed functional test after the drive shaft was rotated back to the home position.When the drive shaft is not in home position it will prevent the lifeband from retracting, thus confirming the reported complaint.Based on the investigation the top cover, bent battery lock clip, and damaged front enclosure were replaced.In summary: the reported complaint of "rattling noises" was due to a broken piece of the plastic top cover loose inside the autopulse.The autopulse top cover had several cracks characteristic of excessive force or impact applied during handling.The ua 45 safety alert was reproduced during testing and resulted from the encoder drive shaft not being rotated back to the home position.The autopulse platform was repaired and passed final testing.The autopulse instructions for use (ifu) instructs the user to ensure that the lifeband is in the home position prior to removal to avoid ua 45.

Event Description

It was reported that during a device check the lifeband would not retract when installed in the autopulse platform (s/n (b)(4)).It was also reported that a rattling noise was heard when the platform was moved around.No patient involved with this event.No additional information was provided.

• 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: 5408712
• MDR Text Key: 37438958
• Report Number: 3010617000-2016-00054
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/03/2016

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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