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

Model Number MODEL 100

Device Problem Device Inoperable (1663)

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

Event Date 02/20/2015

Event Type  malfunction  

Event Description

It was reported that during a device check, the autopulse platform stopped performing compressions after a few minutes.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Zoll (b)(4) confirmed the reported event as the platform stopped operation within 10 minutes and displayed a user advisory 17 (max motor on time exceeded during active operation) message.Zoll (b)(4) indicated that the encoder may be defective as the brake gap, pdb/pca and motor controller were fine.The autopulse platform in complaint was sent to zoll (b)(4) for further investigation.However, zoll (b)(4) has not yet received the platform.A supplemental report will be filed when the product is returned and investigation has been completed.

Manufacturer Narrative

Please note that the product will not be returned to zoll (b)(4) for evaluation.A suppemental report will be filed when the product is returned and an investigation has been completed.

• 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: 4670362
• MDR Text Key: 5624844
• Report Number: 3010617000-2015-00214
• 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: Initial,Followup
• Report Date: 03/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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