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

Model Number MODEL 100

Device Problems Positioning Failure (1158); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll (b)(4) for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that during a device check, customer found that the autopulse lifeband was loose and came off of the autopulse platform.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform was returned to zoll (b)(4) for analysis.Investigation results are as follows: visual inspection was performed and no physical damages were observed.A review of the autopulse platform's archive data was performed and no user advisories or warnings were observed on the reported event date of (b)(6) 2015.Functional evaluation of the returned autopulse platform was performed and the customer's reported complaint of the lifeband being loose and falling off the autopulse was not duplicated.Unrelated to the reported complaint, investigation found that the driveshaft was difficult to rotate.The clutch plate was deburred to address this issue.Following deburring of the clutch plate, the platform passed all functional testing.Based on the investigation, no parts were replaced to address the customer's reported complaint.In summary, the customer's reported complaint of the lifeband being loose was not confirmed during functional testing.Unrelated to the customer's reported complaint, it was observed that the driveshaft was difficult to rotate and is attributed to the clutch plate needing to be deburred.Following service, the platform 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: 4948086
• MDR Text Key: 23112915
• Report Number: 3010617000-2015-00419
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Followup
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2011
• 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