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

Model Number MODEL 100

Device Problems Crack (1135); Device Displays Incorrect Message (2591)

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

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the autopulse platform s/n (b)(4) displayed a system error.It was also reported that the blue case was cracked.No patient information or involvement was disclosed.No additional information was provided.

Manufacturer Narrative

The autopulse platform in complaint was evaluated and serviced in zoll (b)(4) on 01/07/2016.Visual inspection of the returned platform was performed and found physical damages to the front cover and displayed image was flickering.A review of the platform's archive data was performed and found that a user advisory (ua) 139 (unable to hold compression position) message occurred on (b)(6) 2015, thus confirming the customer's reported complaint.The reported ua 139 message was also duplicated during functional testing.The system processor was reset and cleared to remove the system error message.Unrelated to the reported complaints, the brake pads gap was found out of specification and continued even after adjustments were made.In summary, the customer's reported complaint of system error message was confirmed during review of the platform's archive data and was also replicated during functional testing.The system processor was reset and the error message was cleared.Further investigation determined that the brake pad gap was out of specification.The platform was repaired and passed all final functional testing.Service (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: 5341317
• MDR Text Key: 35313272
• Report Number: 3010617000-2016-00001
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• 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: 8700-0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2009
• 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