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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Event Description

It was reported that the autopulse platform displayed some error messages and was not working properly.No adverse patient sequelae was reported.No additional details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation on 11/2/2015.Investigation results are as follows: visual inspection of the returned platform was performed and it was found that the battery lock was bent.Please note that the damage observed during visual inspection is unrelated to the customer's reported complaint.A review of the platform's archive was performed and no user advisories or warnings were observed on the reported event date of (b)(6) 2015.Multiple user advisory (ua) 45 (not at "home" position after-on/restart) messages were however observed on other dates, thus confirming the customer's reported complaint.Initial functional evaluation of the returned autopulse platform was unable to be performed as a user advisory (ua) 45 was observed upon power up.Further inspection identified the cause to be that the driveshaft was out of its "home" position.After the driveshaft was rotated back to the "home" position, the platform was run with a large resuscitation test fixture (lrtf) for approximately 10 minutes and no additional faults or warnings were observed.Based on the investigation, the parts identified for replacement were the battery lock and clutch plate.In summary, the reported complaint of the platform displaying error codes and not working properly was confirmed through platform archive review and functional testing.Multiple user advisory 45 codes were observed in the archive and a ua 45 was displayed upon power up.The ua 45 codes were due to the driveshaft not being in the "home" position, possibly as a result of the lifeband straps not being fully extended prior to pressing start.The physical damages found during inspection and servicing of the device are unrelated to the reported complaint.The platform is a reusable device and therefore, these types of physical damages can occur due to normal wear and tear and/or physical abuse.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

• 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: 5199537
• MDR Text Key: 30326656
• Report Number: 3010617000-2015-00608
• 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,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• 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