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

Model Number MODEL 100

Device Problem Component Falling (1105)

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

Event Date 02/06/2015

Event Type  malfunction  

Event Description

It was reported that upon deployment, during patient use, the lifeband dropped out of the autopulse lifeband channel.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Complainant also alleged that the reported issue has been confirmed by a zoll sales rep.Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and the customer's reported complaint of the lifeband falling out of the platform channel die cast assembly was confirmed.Visual inspection of the autopulse platform indicated that the channel in which the lifeband connects onto the autopulse platform was the cause of the issue.Further investigation into the issue identified that there was unintended variability at the upper end of the "channel".Unrelated to the reported complaint, the bottom cover was also found to be damaged.From the condition of the unit, this damage appeared to have been caused by normal wear and tear.During evaluation, a test lifeband was found to not be locking and clipping onto the roller belt as intended.The lifeband was falling out of the channel, thus confirming the reported complaint.Following replacement of the die cast channel, the autopulse platform was functionally evaluated using a test mannequin and the results indicated that the loose lifeband issue was resolved and the autopulse platform passed all testing criteria.A review of the platform archive was performed and multiple user advisory (ua) 18 (max take-up revolutions exceeded) messages were observed on the reported event date.Based on the archive data, the cause for the ua 18 codes is that no load was detected on the platform's load plate.Based on the investigation, the parts identified for replacement were the channel die cast assembly and bottom cover.In summary, the reported complaint was confirmed during visual inspection and is attributed to the platform channel die cast assembly.Further investigation into the issue identified that there was unintended variability at the upper end of the "channel.Following service, including replacement of the die cast channel and bottom cover, the device passed all testing criteria.

• 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: 4573402
• MDR Text Key: 22033768
• Report Number: 3010617000-2015-00135
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2015

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: 03/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2011
• 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