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

Model Number MODEL 100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on12/16/2015 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 patient use the autopulse platform s/n (b)(4) stopped compressions.The crew had to revert to manual cpr.There were no negative effects to the patient.No additional information provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 12/16/2015.Visual inspection of the returned platform was performed and found hole in the load plate cover, cut head restrain wire and damaged bumper.The lcd screen displayed horizontal lines and had missing pixels.Physical damage was visible on the front and back cover of platform.A review of the platform's archive data was performed and several user advisories (ua) on the event, thus confirming the customer's reported complaint.Ua 17 (max motor on time exceeded during active operation), ua 2 (compression tracking error), ua 18 (max take-up revolution exceeded) and ua 1 (low battery warning) were all observed on (b)(6) 2015.The reported ua error messages were not reproducible during functional testing.The platform passed all functional test.Unrelated to the reported complaints, the platform failed the load cell characterization test.In summary, the customer's reported complaint of system error messages were confirmed during review of the platform's archive data.The physical damage on the platform was repaired and the device passed all final functional testing.

• 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: 5338847
• MDR Text Key: 34885771
• Report Number: 3010617000-2015-00699
• 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: Initial,Followup
• Report Date: 03/30/2016

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2007
• 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
• Patient Age: 74 YR