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

Model Number MODEL 100

Device Problems Break (1069); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

It was reported that during a device check, the autopulse platform displayed user advisory messages and did not perform compressions.Customer did not know what the exact messages were.It was also reported that the steel strap near the head of the platform was broken.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/11/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection was performed and the following parts were found to have been damaged: the top cover and battery lock.The reported complaint of the top cover's head restraint wires being damaged was confirmed based on the damages observed on the top cover.From the condition of the returned platform, the damages appear to have been due to wear and tear.The platform was tested with a large resuscitation test fixture for 15 minutes, with no faults observed.The reported complaint of the platform not performing compressions could not be duplicated.The platform performed as intended during functional evaluation.A review of the platform's archive data was performed and found no user advisory codes on the reported event date of (b)(6) 2015.Based on the investigation, the parts identified for replacement were the top cover and the battery lock.In summary, the reported complaint of the top cover's head restraint wires being damaged was confirmed based on visual inspection and attributed to wear and tear.The reported complaint of the platform not performing compressions could not be duplicated.The platform performed as intended during functional evaluation.Review of the platform's archive data found no user advisories on the reported event date.Following service, including replacement of the damaged top cover and battery lock, 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: 4517696
• MDR Text Key: 5495381
• Report Number: 3010617000-2015-00098
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 02/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2010
• 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