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

Model Number MODEL 100

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 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 a shift check, the display screen of the autopulse platform was blank with vertical lines seen on it when the device was powered on.Customer reported that this occurred intermittently upon power on.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

(b)(6).The autopulse platform was returned to the manufacturer for evaluation 08/27/2015.Investigation results as follows: visual inspection of the returned platform was performed and no physical damages were observed.The autopulse lifeband and soft carry case were also returned with the autopulse platform and no physical damages were observed.A review of the platform's archive data was performed and no issues 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 display screen being blank and exhibiting vertical lines was confirmed.Further inspection identified that the lcd ribbon cable that connects to the processor board needed to be cleaned.After reinstalling and cleaning the lcd ribbon cable with alcohol, the issue was resolved.The autopulse platform was powered cycled and run with a large resuscitation test fixture (lrtf) for 5 minutes and no other issues were observed.Based on the investigation no parts were identified for replacement.In summary, the customer's reported complaint was confirmed during functional testing.The root cause of the reported issue was determined to be that the lcd ribbon cable that connects to the processor board needed to be cleaned.Once the lcd ribbon was cleaned, the issue was resolved and the autopulse platform 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: 5059345
• MDR Text Key: 25778210
• Report Number: 3010617000-2015-00508
• 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
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2015
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2010
• 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