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

Model Number MODEL 100

Device Problems Break (1069); Retraction Problem (1536); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

It was reported that both head restraints of the autopulse platform were damaged and the load plate screws were missing.The customer also reported that the lifeband will not retract.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 06/03/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and it was observed that the head restraint wire was broken and one of the load plate screws was missing.The front enclosure, battery lock and battery compartment were also observed to be damaged.Based on the condition of the returned platform, the damage appears to have been due to wear and tear.Functional testing was performed and the reported complaint of the lifeband being unable to retract was confirmed.The platform displayed a user advisory (ua) 16 (timeout moving to take-up position).Inspection of the device identified the cause to be that the drive train motor brake had seized up.Upon cleaning and re-adjusting the brake gap back within specification, the platform performed as intended with no other user advisories or warnings exhibited.A review of the archive was performed and no user advisories or warnings were observed on the reported event date of (b)(6) 2015.Based on the initial investigation, the parts identified for replacement were the top cover, the load plate screw, the front enclosure, the battery lock and the battery compartment.The drivetrain motor brake was cleaned and readjusted back within specification to remedy the reported complaint.In summary, the reported complaint was confirmed during functional testing and is attributed to the drivetrain motor brake seizing up.Following service, including cleaning and re-adjusting the brake gap back within specification, the device passed all testing criteria.

• 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: 4860825
• MDR Text Key: 5844789
• Report Number: 3010617000-2015-00351
• 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: 05/28/2015

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: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2007
• 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