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

Model Number MODEL 100

Device Problem Unable to Obtain Readings (1516)

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

Event Date 05/26/2015

Event Type  malfunction  

Event Description

It was reported that when the autopulse platform was powered on, horizontal lines appeared on the lcd display and the screen is unreadable.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform (b)(4) was returned to the manufacturer for evaluation.Visual inspection was performed which found that the top cover, front enclosure and bottom enclosure were damaged.Functional testing was performed and the customer's reported complaint was unable to be duplicated.The platform was power cycled and no faults were found with the lcd display.A review of the platform's archive was performed and no faults or errors were observed on the reported event date (b)(6) 2015.Based on the investigation the parts identified for replacement were the top cover, front enclosure and bottom enclosure.No repairs were made to remedy the customer's reported complaint.The lcd display however, was replaced as a precaution.In summary, the customer's reported complaint was not confirmed as the issue was unable to be duplicated during functional testing.The device was powered on approximately 15 times and the reported complaint was not observed.Since the reported complaint was unable to be confirmed, a root cause could not be determined.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4846323
• MDR Text Key: 5939867
• Report Number: 3010617000-2015-00334
• Device Sequence Number: 1
• Product Code: DRM
• 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
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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