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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n: (b)(4)) was returned for evaluation.The customer reported complaint was confirmed during archive review but not during initial functional testing.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported complaint.The platform is working as intended for use.No physical damage was observed during visual inspection.Review of the archive data indicated error message ua 21 on january 31, 2017, but not on the customer reported date.This fault indicates that the computed compression target position exceeds allowable revolutions and the spool shaft turns in the wrong direction.The platform passed the initial functional testing without any fault or error.A run-in test was performed using the 95% patient large resuscitations test fixture (lrtf) with a known good test batteries until discharge without any fault.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 training, the autopulse platform (sn: (b)(4)) stopped performing compression and displaying an error message user advisory 21 (position change does not coincide with motor direction).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: 6678622
• MDR Text Key: 78733663
• Report Number: 3010617000-2017-00430
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2017

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: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2011
• 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