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

Model Number MODEL 100

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

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

Event Date 06/06/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform displayed a user advisory 41 (patient temperature sensor failure) message that could not be cleared.In addition, the head restraint was found to be damaged.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: visual inspection was performed and the following was observed: the head restraint wire was cut/broken and the front enclosure was cracked.Based on the condition of the returned platform, the observed damages were due to wear and tear.During power on of the platform, a user advisory (ua) 7 fault (discrepancy between load 1 and load 2 too large) was displayed on the platform.Inspection of the device determined a failed load cell was the cause for the ua 7.The ua 7 fault is considered unrelated to the reported complaint.The reported user advisory (b)(4) message (patient temperature sensor failure) was not observed during functional testing.The platform ran for 15 minutes with a large resuscitation test fixture and an additional 10 minutes with a test mannequin with no faults observed.A review of the archive did not show the reported ua (b)(4) occurring on the reported event date of (b)(6) 2014.The fault was however observed on other dates, including most recently on (b)(6) 2014.Based on the investigation, the part(s) identified for replacement were the top cover, front enclosure, single point load cell.The patient temperature sensor was also replaced as a precaution to prevent future ua (b)(4) errors.In summary, the reported complaint of a ua (b)(4) fault occurring was confirmed during archive review.The patient temperature sensor was replaced as a precaution to prevent future ua (b)(4) errors.During functional testing, a ua 7 fault was displayed and attributed to a failed load cell.The reported complaint of the head restraint being damaged was confirmed during visual inspection and attributed to wear and tear.Following replacement of the damaged parts as well as the load cell and patient temperature sensor, the device passed all testing criteria.

• 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: 3914084
• MDR Text Key: 4515458
• Report Number: 3003793491-2014-00318
• 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
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• 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: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2007
• 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