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

Model Number MODEL 100

Device Problem Malposition of Device (2616)

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

Event Date 08/22/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse platform consistently displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.The message cleared when the customer reset the driveshaft to the "home" position; however, the ua 45 message appeared again the next time that the platform was powered on.The customer mentioned that when they tried to rotate the driveshaft to the "home" position the second time, the home position was not set properly to where they could insert the lifeband.It appeared as if the "home" position was off by 180 degrees.No adverse patient sequelae was reported.No further information was provided.

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.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 09/08/2014 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found the motor cover to be damaged.The physical damage found during visual inspection is unrelated to the customer's reported complaints of a user advisory (ua) 45 (not at "home" position after power-on/restart) and that the "home" position was off by 180 degrees.The returned platform underwent and passed initial functional testing.The system was turned on/off with no problems and ran for 15 minutes using a large resuscitation test fixture (lrtf) with no anomalies or errors exhibited.A review of the platform's archive was performed and found multiple ua 45 faults to have occurred on the reported event date of (b)(6) 2014.Per the autopulse technical service guide (p/n 11377-006), ua 45 is exhibited when the lifeband is not fully extended, or if the encoder is not in the "home" position.As there were no issues identified during functional testing associated with ua 45, the root cause of the exhibited ua 45 was determined to be that the lifeband was not fully extended, causing the encoder to not be at the "home" position.The autopulse® was designed to exhibit ua 45 to prevent patient harm.Based on the investigation, the part identified for replacement was the motor cover.The platform underwent and passed all final functional testing.In summary, the customer's reported complaint of the platform exhibiting a ua 45 was confirmed through review of the platform's archives; however, the complaint of the driveshaft appearing to be off by 180 degrees was not confirmed.The ua 45 was unable to be duplicated during investigation and the driveshaft was determined to be in the correct position.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4090771
• MDR Text Key: 4761676
• Report Number: 3010617000-2014-00466
• 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,Followup
• Report Date: 08/22/2014

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 09/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2006
• 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