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

Model Number MODEL 100

Device Problem Positioning Failure (1158)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

Product in complaint was returned to zoll on 09/16/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Event Description

It was reported that the autopulse lifeband is loose and will not seat properly with the metal shaft.The customer exchanged the lifeband with a new one, however the issue would not resolve.This was observed during a shift check.There was no report of any patient involvement.No additional details were provided.

Manufacturer Narrative

The autopulse platform (23223) was returned to the manufacturer for evaluation on 09/16/2015.Investigation results as follows: visual inspection of the returned platform was performed and no physical damages were observed.A review of the autopulse platform's archive was reviewed and a user advisory (ua) 45 (not at "home" position after power-on/restart) was observed on the reported event date of (b)(6) 2015.This user advisory is however unrelated to the customer's reported complaint of the lifeband being loose and not seating properly in the metal shaft.Functional evaluation of the returned autopulse platform was performed and it was observed that the autopulse lifeband was unable to lock in place.The channel roller assembly was found to be at fault.Following replacement of the channel roller assembly, the platform passed all functional testing.Based on the investigation, the part identified for replacement was the channel roller assembly.In summary, the customer's reported complaint of the lifeband being loose and not seating properly was confirmed.It was found that the channel roller assembly was at fault.Unrelated to the reported complaint, the autopulse platform displayed a user advisory (ua) 45 message on the reported event date.Per the autopulse resuscitation system model 100 user guide,the autopulse driveshaft has a "home" position that is a point of reference for autopulse operation.If the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user the part identified during investigation, the platform successfully passed all final functional testing.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 5125486
• MDR Text Key: 27416731
• Report Number: 3010617000-2015-00544
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• 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: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2011
• 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