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

Model Number MODEL 100

Device Problems Loss of Power (1475); Noise, Audible (3273)

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

Event Date 04/07/2015

Event Type  malfunction  

Event Description

It was reported that during a device check, the autopulse platform stopped and made a noise when the autopulse lifeband adjusted to the mannequin's chest.No patient involvement was reported.No further information was provided.

Event Description

Additional information provided: the autopulse platform also displayed a user advisory (ua) 2 (compression tracking error) message on the reported event date during the customer's daily check of the device.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll (b)(4) on (b)(6) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Please note that zoll (b)(4) received an initial call on (b)(6) 2015 from the distributor about a device return.At that time, details of the malfunction was not reported by them.The platform arrived at zoll (b)(4) on (b)(6) 2015 without knowledge of any complaint.Information regarding the event was reported to zoll (b)(4) on (b)(6) 2015.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform was performed and found no visible or physical damages to the platform.A review of the platform's archive data was performed and found that a user advisory (ua) 2 (compression tracking error) message occurred on the reported event date of (b)(6) 2015, thus confirming the customer's reported complaint of a ua 2 message.The reported complaint that the autopulse platform stopped, made a noise when the autopulse lifeband adjusted to the mannequin's chest and displayed a ua 2 message was duplicated during functional testing.Further inspection of the device revealed that the load cell amp cable was not connected properly because the connector on the processor pca board that connects to the load cell amp cable was damaged.Because the load cell amp cable was not connected, pressure was applied to the load cell before "take up" of the lifeband was completed, thus resulting in a ua 2 message.Based on the investigation, the part identified for replacement was the processor pca board.After replacement of the processor pca board, it was observed that the shape of the load cell amp cable was different so the cable was also replaced.In summary, the customer's reported complaint that the autopulse platform stopped, made a noise when the autopulse lifeband adjusted to the mannequin's chest and displayed a ua 2 message was confirmed during review of the platform's archive data and also duplicated during functional testing.The root cause was determined to be a damaged connector on the processor pca board.After replacement of the processor pca board and the load cell amp cable, the platform passed all final functional 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: 4759665
• MDR Text Key: 5782578
• Report Number: 3010617000-2015-00269
• 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,Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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