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

Model Number MODEL 100

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

It was reported that during an evaluation of the autopulse platform (s/n (b)(4) prior to use the device showed missing pixels in the platform display screen.No patient involved during this event.No additional information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation.The customer's reported complaint that the platform showed missing pixels in the display screen were confirmed during visual inspection but not during functional testing.The lcd screen was replaced to remedy the issue.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.Therefore, the exact root cause could not be determined.The autopulse platform is a reusable device and was manufactured on 12/29/2011.Therefore, this type of damage found is characteristic of normal wear and tear for the life of the device.After replacing the lcd screen, the platform passed all final functional testing criteria.A review of the platform archive was performed and there were no problems found in the internal log.Additionally, visual inspection showed no damages to the platform.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

• 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: 6045612
• MDR Text Key: 58018577
• Report Number: 3010617000-2016-00737
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001250
• UDI-Public: 00849111001250
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2011
• 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