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

Model Number MODEL 100

Device Problem No Display/Image (1183)

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

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Product in complaint was returned to zoll on 10/02/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Event Description

It was reported that the lcd display of the autopulse platform is green and blank and no characters were able to be seen.A fully charged li-ion battery was being used at the time when this issue occurred.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll on 10/02/2015.Investigation results as follows: visual inspection of the returned platform was performed and found that the platform screen was blank and green and was not displaying any data.In addition, corrosion was observed on the top cover, processor board, power distribution board (pdb), drive train, integrated encoder gearbox and most of the connectors.The brakes had also seized.Based on these observations, it appears that some kind of liquid has been inside the platform for an unknown length of time.In summary the customer's reported complaint that the autopulse platform shows a blank green screen was confirmed during visual inspection.The damages noted during visual inspection are attributed to some kind of liquid being inside the platform for an unknown length of time.It was recommended that the platform be scrapped.Please note that the autopulse user guide recommends storing the platform in a cool, dry place in a carry case, hygiene barrier or transporter.

• 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: 5164483
• MDR Text Key: 28800704
• Report Number: 3010617000-2015-00569
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Followup
• Report Date: 09/24/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• 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